HXY
7 FDA 510(k) clearances · Product code
48 daysmedian time to decision
161 days90th percentile
7clearances measured
FDA profile
- Official device name
- Brace, Drill
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2001: 1 · 2002: 1 · 2003: 3 · 2005: 6 · 2006: 2 · 2007: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BENDEREV DRILL GUIDE (K923776) | Neimark Labs, Inc. | 1992-11-06 |
| MITEK DRILL GUIDE (K892904) | Mitek Surgical Products, Inc. | 1989-09-28 |
| BONE SUTURE FIXATION DEVICE (K880264) | Orthopedic Systems, Inc. | 1988-03-23 |
| TELOS DISTAL TARGETING DEVICE (K880381) | Austin Assoc. | 1988-03-15 |
| HASTING FINGER FIXATOR INSTRUMENTS (K880046) | Buckman Co., Inc. | 1988-02-16 |
| ANDREWS REMOTE CHUCK DRILL (K831043) | Orthopedic Systems, Inc. | 1983-04-28 |
| CEMENT EXTRACTOR DRILL (K770204) | Depuy, Inc. | 1977-02-08 |
Track HXY automatically
Every clearance here is in the API, with alerts when new ones post.