Panels › Orthopedic › Product code KWQ · Class 2

Appliance, Fixation, Spinal Intervertebral Body

Regulation 888.3060

11510(k)s in 12 months (668 all time)

1recalls in 12 months (214 all time)

165recalls that name a 510(k)

Get daily alerts for KWQ Sample brief CSV

Top companies in KWQ

Company	510(k)s	Recalls
Stryker Spine	6	38
Alphatec Spine, Inc.	9	32
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	0	41
Zimmer, Inc.	1	37
Medtronic Sofamor Danek	29	8
Nuvasive, Inc.	21	0
K2m	20	0
Depuy Spine, Inc.	10	8
Blackstone Medical, Inc.	13	3
Globus Medical, Inc.	15	0

Date	Firm and product	Code	Linked 510(k)
Apr 15, 2026	Clariance-SAS Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Cata Open, Classified	KWQ	K243904
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439 Terminated	KWQ	K200995
Apr 26, 2021	Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422 Terminated	KWQ	K200995
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

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.