LYT
9 FDA 510(k) clearances · Product code
65 daysmedian time to decision
130 days90th percentile
9clearances measured
FDA profile
- Official device name
- Fixation Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2006: 2 · 2009: 5 · 2012: 13
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 |
|---|---|---|
| CERAMIC TIPPED SKULL PIN (K040363) | The Jerome Group, Inc. | 2004-04-12 |
| BONE BAND (K983685) | Chapel and Assoc. | 1998-12-04 |
| OSTEONICS FX-CABLELOK GRIP COMPONENTS (K980594) | Osteonics Corp. | 1998-05-05 |
| K-CAP-E, STERILE (K914812) | Westcon Orthopedics, Inc. | 1992-01-09 |
| K-CAP-I, STERILE (K912762) | Westcon Orthopedics, Inc. | 1991-07-18 |
| MICROGUARD, ORTHOPEDIC PIN PROTECTORS (K902676) | Micro-Aire Surgical Instruments, Inc. | 1990-09-14 |
| K-CAP-I ORTHOPEDIC FIXATION WIRE CAP (K902053) | Westcon Orthopedics, Inc. | 1990-09-14 |
| HORIZON ORTHOPEDIC PIN PROTECTOR (K883576) | Horizon Medical, Inc. | 1988-09-30 |
| JURGAN PIN BALL (K831072) | Jurgan Development & Mfg., Ltd. | 1983-06-08 |
Track LYT automatically
Every clearance here is in the API, with alerts when new ones post.