HXY — Brace, Drill Class I
FDA product code HXY covers "Brace, Drill", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HXY
- Device Class
- Class I
- Regulation Number
- 888.4540
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K923776 | neimark labs | BENDEREV DRILL GUIDE | November 6, 1992 |
| K892904 | mitek surgical products | MITEK DRILL GUIDE | September 28, 1989 |
| K880264 | orthopedic systems | BONE SUTURE FIXATION DEVICE | March 23, 1988 |
| K880381 | austin assoc | TELOS DISTAL TARGETING DEVICE | March 15, 1988 |
| K880046 | buckman co | HASTING FINGER FIXATOR INSTRUMENTS | February 16, 1988 |
| K831043 | orthopedic systems | ANDREWS REMOTE CHUCK DRILL | April 28, 1983 |
| K770204 | depuy | CEMENT EXTRACTOR DRILL | February 8, 1977 |