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)
Top companies in OAR
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2024 | Merit Medical Systems, Inc. StabiliT TOUCH Syringe, REF: IN8VCF/B Open, Classified |
OAR | None listed |
| Jul 3, 2024 | Stryker 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 |
OAR | None listed |
| Feb 13, 2020 | Merit 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 |
OAR | None listed |
| Feb 13, 2020 | Merit 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 |
OAR | None listed |
| Dec 6, 2017 | Medtronic 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 |
OAR | None listed |
| Nov 9, 2017 | Stryker 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 |
OAR | None listed |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307
for spinal orthopedic use. Terminated |
OAR | None listed |
| May 17, 2017 | Medtronic Sofamor Danek USA Inc KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R. Terminated |
OAR | None listed |
| Nov 27, 2013 | Synthes USA HQ, Inc. Vertebroplasty Needle Kit 10g Diamond Tip
Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure. Terminated |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| May 24, 2013 | Orthovita, 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 |
OAR | None listed |
| Jul 3, 2012 | DePuy 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 |
OAR | None listed |
| Jul 3, 2012 | DePuy 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 |
OAR | None listed |
| Jul 3, 2012 | DePuy 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 |
OAR | None listed |
| Jul 3, 2012 | DePuy 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 |
OAR | None listed |
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