Panels › Orthopedic › Product code HWT · Class 1
Template
Regulation 888.4800
0510(k)s in 12 months (10 all time)
0recalls in 12 months (85 all time)
21recalls that name a 510(k)
Top companies in HWT
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Inc. | 0 | 46 |
| Waldemar Link GmbH & Co. KG (Corp. Hq.) | 0 | 21 |
| Biomet, Inc. | 1 | 4 |
| Stryker Howmedica Osteonics Corp. | 0 | 4 |
| DePuy Orthopaedics, Inc. | 0 | 3 |
| Aesculap Implant Systems LLC | 0 | 2 |
| Depuy, Inc. | 2 | 0 |
| 3M Company | 1 | 0 |
| Biomet Microfixation, LLC | 0 | 1 |
| Encore Medical, Lp | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2012 | Zimmer, Inc. 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28
00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28
00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28
00780302804 M Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26
00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26
00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26
00780302604 M Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22
00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22
00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22
The provisiona Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 12/14 Neck Taper
00789504001 VerSys Femoral Head Provisional 40mm -3.5
00789504002 VerSys Femoral Head Provisional 40mm +0
00789504003 VerSys Femoral Head Provisional 40mm +3.5
00789504004 VerSys Femo Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 00789503601 VerSys Femoral Head Provisional 36mm -3.5
00789503602 VerSys Femoral Head Provisional 36mm +0
00789503603 VerSys Femoral Head Provisional 36mm +3.5
00789503604 VerSys Femoral Head Provisio Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 12/14 Neck Taper
00789503201 VerSys Femoral Head Provisional 32mm -3.5
00789503202 VerSys Femoral Head Provisional 32mm +0
00789503203 VerSys Femoral Head Provisional 32mm +3.5
00789503204 VerSys Femo Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 00789502801 VerSys Femoral Head Provisional 28mm -3.5
00789502802 VerSys Femoral Head Provisional 28mm +0
00789502803 VerSys Femoral Head Provisional 28mm +3.5
00789502804 VerSys Femoral Head Provisio Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 00789502601 VerSys Femoral Head Provisional 26mm -3.5
00789502602 VerSys Femoral Head Provisional 26mm +0
00789502603 VerSys Femoral Head Provisional 26mm +3.5
00789502604 VerSys Femoral Head Provisio Terminated |
HWT | None listed |
| Sep 28, 2012 | Zimmer, Inc. 00789502202 VerSys Femoral Head Provisional 22mm +0
00789502203 VerSys Femoral Head Provisional 22mm +3.5
00789502220 VerSys Femoral Head Provisional 22mm -2
00789502230 VerSys Femoral Head Provisiona Terminated |
HWT | None listed |
| Jul 31, 2012 | Aesculap Implant Systems LLC Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US)
Product Usage:
The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in Terminated |
HWT | None listed |
| Dec 14, 2010 | Zimmer Inc. Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN. Terminated |
HWT | None listed |
| Jan 23, 2009 | Zimmer Inc. Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 12 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-12.
Used during total knee arthroplas Terminated |
HWT | None listed |
| Jan 23, 2009 | Zimmer Inc. Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-14.
Used during total knee arthroplas Terminated |
HWT | None listed |
| Sep 16, 2008 | Stryker Howmedica Osteonics Corp. OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the Terminated |
HWT | None listed |
| Sep 16, 2008 | Stryker Howmedica Osteonics Corp. OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the ma Terminated |
HWT | None listed |
| Aug 23, 2008 | Stryker Howmedica Osteonics Corp. Stem Trial, Triathlon Revision Instruments; Non-Sterile; 150 mm length
Catalog Numbers:
5566-T-009, 5566-T-010, 5566-T-011, 5566-T-012, 5566-T-013, 5566-T-014
5566-T-015, 5566-T-016, 5566-T-017, 5566- Terminated |
HWT | None listed |
| Aug 23, 2008 | Stryker Howmedica Osteonics Corp. Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length
Catalog numbers:
5565-T-009, 5565-T-010, 5565-T-011, 5565-T-012, 5565-T-013, 5565-T-014
5565-T-015, 5565-T-016, 5565-T-017, 5565 Terminated |
HWT | None listed |
| Mar 28, 2008 | Biomet, Inc. Biomet Vanguard Knee Instrumentation, Part Number: 32-487062, 67.5/70/75mm Sizing Wing, Biomet UK Ltd, Made in Britain; The device is a preparatory instrument used for femoral knee insertion. (Distrib Terminated |
HWT | None listed |
| Mar 28, 2008 | Biomet, Inc. Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used for femoral knee insertion. Terminated |
HWT | None listed |
| Nov 22, 2006 | Zimmer Inc. Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10. Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 14 mm diameter, 170 mm length, non-sterile, catalog no. 4309-14-17 (00-4309-014-17). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 12 mm diameter, 170 mm length, non-sterile, catalog no. 4309-12-17 (00-4309-012-17). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 10 mm diameter, 170 mm length, non-sterile, catalog no. 4309-10-17 (00-4309-010-17). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 8 mm diameter, 170 mm length, non-sterile, catalog no. 4309-08-17 (00-4309-008-17). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 18 mm diameter, 130 mm length, non-sterile, catalog no. 4309-18-13 (00-4309-018-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 17 mm diameter, 130 mm length, non-sterile, catalog no. 4309-17-13 (00-4309-017-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 16 mm diameter, 130 mm length, non-sterile, catalog no. 4309-16-13 (00-4309-016-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 15 mm diameter, 130 mm length, non-sterile, catalog no. 4309-15-13 (00-4309-015-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 14 mm diameter, 130 mm length, non-sterile, catalog no. 4309-14-13 (00-4309-014-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 13 mm diameter, 130 mm length, non-sterile, catalog no. 4309-13-13 (00-4309-013-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 12 mm diameter, 130 mm length, non-sterile, catalog no. 4309-12-13 (00-4309-012-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 11 mm diameter, 130 mm length, non-sterile, catalog no. 4309-11-13 (00-4309-011-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 10 mm diameter, 130 mm length, non-sterile, catalog no. 4309-10-13 (00-4309-010-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 9 mm diameter, 130 mm length, non-sterile, catalog no. 4309-09-13 (00-4309-009-13). Terminated |
HWT | None listed |
| Jul 27, 2006 | Zimmer Inc. Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 8 mm diameter, 130 mm length, non-sterile, catalog no. 4309-08-13 (00-4309-008-13). Terminated |
HWT | None listed |
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