LYT — Fixation Accessory Class II
FDA product code LYT covers "Fixation Accessory", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LYT
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K040363 | jerome group | CERAMIC TIPPED SKULL PIN | April 12, 2004 |
| K983685 | chapel and assoc | BONE BAND | December 4, 1998 |
| K980594 | osteonics | OSTEONICS FX-CABLELOK GRIP COMPONENTS | May 5, 1998 |
| K914812 | westcon orthopedics | K-CAP-E, STERILE | January 9, 1992 |
| K912762 | westcon orthopedics | K-CAP-I, STERILE | July 18, 1991 |
| K902676 | micro-aire surgical instruments | MICROGUARD, ORTHOPEDIC PIN PROTECTORS | September 14, 1990 |
| K902053 | westcon orthopedics | K-CAP-I ORTHOPEDIC FIXATION WIRE CAP | September 14, 1990 |
| K883576 | horizon medical | HORIZON ORTHOPEDIC PIN PROTECTOR | September 30, 1988 |
| K831072 | jurgan development and mfg | JURGAN PIN BALL | June 8, 1983 |