Company

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)

50recalls (0 in 12 months)

9recalls that name a 510(k)

Product codes

Code	Device	Records
KWQ	Appliance, Fixation, Spinal Intervertebral Body	41
OLO	Orthopedic Stereotaxic Instrument	4
KWP	Appliance, Fixation, Spinal Interlaminal	3
JDQ	Cerclage, Fixation	1
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
No clearances in this window.

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	K183060
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Jan 15, 2021	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified	KWQ	None listed
Nov 2, 2020	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation de Open, Classified	OLO	K200095
Oct 27, 2020	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MD Terminated	OLO	K200095
Oct 27, 2020	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04- Terminated	OLO	K200095
Sep 11, 2020	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN Terminated	OLO	K200095
Oct 20, 2016	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junctio Terminated	KWP	K150254
May 26, 2016	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument. Terminated	KWP	K150254
Mar 18, 2016	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver Terminated	KWP	K150254
Jul 9, 2015	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated. Terminated	JDQ	None listed
Jun 26, 2015	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13- Terminated	MAX	K133455

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