510(k) K965098 ยท HSB Rod, Fixation, Intramedullary And Accessories
INTRAMEDULLARY NAIL SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 28, 1997 |
| Received | Dec 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965098
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2017 | Zimmer Biomet, Inc. FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM
FEM IM NAIL 14MMDX32CM
FEM IM NAIL 15MMDX32CM
FEM IM NAIL 16MMDX32CM
FEM IM NAIL 14MMDX34CM
FEM IM NAIL 15MMDX34CM
FEM IM NAIL 16MMDX34CM
FEM IM Terminated |
HSB | None listed |
| Apr 28, 2017 | Zimmer Biomet, Inc. TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM
TIBIAL I/M NAIL 15MMDX30CM
TIBIAL I/M NAIL 14MMDX32CM
TIBIAL I/M NAIL 15MMDX32CM
TIBIAL I/M NAIL 14MMDX34CM
TIBIAL I/M NAIL 15MMDX34CM
TIBI Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Por fullct fem st 20x200mm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 16mmdx38cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 16mmdx40cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 16mmdx42cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 15mmdx44cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 16mmdx44cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 15mmdx46cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 16mmdx46cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 15mmdx48cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 16mmdx48cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 15mmdx50cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 16mmdx50cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Tibial IM Nail 15mmdx44cm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental malefemale taper, 220mm, Sterile,
Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants Terminated |
KRO | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental fluted stem, 17x190mm str, Sterile,
Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants Terminated |
KRO | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental fluted stem, 18x190mm str, Sterile,
Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants Terminated |
KRO | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental fluted stem, 19x190mm str, Sterile,
Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants Terminated |
KRO | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental fluted stem, 15x250mm bwd, Sterile,
Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants Terminated |
KRO | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental fluted stem, 16x250mm bwd, Sterile,
Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants Terminated |
KRO | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Segmental fluted stem, 17x250mm bwd, Sterile,
Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants Terminated |
KRO | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 37 consists of all product under product code: HSB and same usage:
Item no:
225302055 INTERLOCKING IM SCREW LG
225303055 INTERLOCKING IM SCREW LG
225304055 INTERLOCKING IM SCREW LG
225304555 Terminated |
HSB | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 42 consists of all product under product code: HSB and same usage:
Item no:
225224010 M/DN FEM IM NAIL 10MM DIA
225228010 M/DN FEM IM NAIL 10MM DIA
225230010 M/DN FEM IM NAIL 10MM DIA
225232 Terminated |
HSB | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 60 consists of all product under product code: HSB and same usage:
Item no:
225207055 RECON SCREW LG 5.5MM DIA
225207555 RECON SCREW LG 5.5MM DIA
225208055 RECON SCREW LG 5.5MM DIA
225208555 Terminated |
HSB | None listed |
| Feb 20, 2014 | Zimmer, Inc. RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525. Terminated |
HSB | None listed |
| Feb 20, 2014 | Zimmer, Inc. INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM.
Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534 Terminated |
HSB | None listed |
| Feb 20, 2014 | Zimmer, Inc. M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543. Terminated |
HSB | None listed |
| Jul 20, 2004 | Zimmer Inc. M/DN Intramedullary Fixation Humeral Nail Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.