Product code HXY
- Device name
- Brace, Drill
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923776 | BENDEREV DRILL GUIDE | Neimark Labs, Inc. | 1992-11-06 |
| K892904 | MITEK DRILL GUIDE | Mitek Surgical Products, Inc. | 1989-09-28 |
| K880264 | BONE SUTURE FIXATION DEVICE | Orthopedic Systems, Inc. | 1988-03-23 |
| K880381 | TELOS DISTAL TARGETING DEVICE | Austin Assoc. | 1988-03-15 |
| K880046 | HASTING FINGER FIXATOR INSTRUMENTS | Buckman Co., Inc. | 1988-02-16 |
| K831043 | ANDREWS REMOTE CHUCK DRILL | Orthopedic Systems, Inc. | 1983-04-28 |
| K770204 | CEMENT EXTRACTOR DRILL | Depuy, Inc. | 1977-02-08 |
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