HTS
9 FDA 510(k) clearances · Product code
48 daysmedian time to decision
386 days90th percentile
9clearances measured
FDA profile
- Official device name
- Knife, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 1999: 1
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 |
|---|---|---|
| CUSTOM ORTHOPAEDIC TRAYS (PACKS) (K930507) | Associated Medical Products Co. | 1994-02-22 |
| ACUFLEX DISPOSABLE KNIVES (K933921) | Acufex Microsurgical, Inc. | 1994-01-26 |
| SPINAL MICROKNIFE (K882525) | Karlin Technology, Inc. | 1988-09-22 |
| TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (K873713) | Arthropedics, Inc. | 1987-11-02 |
| BANANA KNIFE, DISPOSABLE #TM-1612 (K873714) | Arthropedics, Inc. | 1987-11-02 |
| RETROGRADE KNIFE, DISPOSABLE #TM-1613 (K873711) | Arthropedics, Inc. | 1987-11-02 |
| STANDARD KNIFE, DISPOSABLE #TM-1610 (K873712) | Arthropedics, Inc. | 1987-10-15 |
| ARTHROSCOPY KNIVES (K842820) | Medtech Industries, Inc. | 1984-08-14 |
| ARTHROSCOPE OPERATIVE KNIFE SET (K771851) | Richard Wolf Medical Instruments Corp. | 1977-10-27 |
Track HTS automatically
Every clearance here is in the API, with alerts when new ones post.