ClearanceBrief
Panels › Orthopedic › Product code OAR · Class 1

Injector, Vertebroplasty (Does Not Contain Cement)

Regulation 888.4200

0510(k)s in 12 months (1 all time)
0recalls in 12 months (26 all time)
0recalls that name a 510(k)
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Top companies in OAR

DateFirm and productCodeLinked 510(k)
Oct 11, 2024Merit Medical Systems, Inc.
StabiliT TOUCH Syringe, REF: IN8VCF/B
Open, Classified
OARNone listed
Jul 3, 2024Stryker Corporation
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the abil
Open, Classified
OARNone listed
Feb 13, 2020Merit Medical Systems, Inc.
DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT
Terminated
OARNone listed
Feb 13, 2020Merit Medical Systems, Inc.
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 B
Terminated
OARNone listed
Dec 6, 2017Medtronic Sofamor Danek USA Inc
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Terminated
OARNone listed
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Terminated
OARNone listed
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
Terminated
OARNone listed
May 17, 2017Medtronic Sofamor Danek USA Inc
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Terminated
OARNone listed
Nov 27, 2013Synthes USA HQ, Inc.
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bo
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminis
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bo
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminis
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bon
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bo
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or dimin
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened o
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened o
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened o
Terminated
OARNone listed
May 24, 2013Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened
Terminated
OARNone listed
Jul 3, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-
Terminated
OARNone listed
Jul 3, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra
Terminated
OARNone listed
Jul 3, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashio
Terminated
OARNone listed
Jul 3, 2012DePuy Mitek, Inc., a Johnson & Johnson Co.
Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashio
Terminated
OARNone listed

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