Panels › Orthopedic › Product code HWR · Class 1
Driver, Prosthesis
Regulation 888.4540
0510(k)s in 12 months (4 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in HWR
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet U.K., Ltd. | 0 | 2 |
| Warsaw Orthopedic, Inc. | 2 | 0 |
| Biomet Microfixation, Inc. | 0 | 1 |
| Buckman Co., Inc. | 1 | 0 |
| Kim-Med, Inc. | 1 | 0 |
| Pioneer Surgical Technology | 0 | 1 |
| Smith & Nephew, Inc., Endoscopy Div. | 0 | 1 |
| Wright Medical Technology Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2016 | Smith & Nephew, Inc., Endoscopy Div. Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument Terminated |
HWR | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
HWR | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Unicompartmental Knee Phase 3 Tibial Impactor
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
HWR | None listed |
| Apr 11, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT.
Part Number SP-1918
BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32 Terminated |
HWR | None listed |
| Nov 27, 2007 | Pioneer Surgical Technology Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855 Terminated |
HWR | None listed |
| Nov 27, 2007 | Wright Medical Technology Inc Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002 Terminated |
HWR | None listed |
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