OSTEONICS FX-CABLELOK GRIP COMPONENTS
FDA 510(k) clearance K980594 · decided 1998-05-05
Clearance details
- K-number
- K980594
- Device name
- OSTEONICS FX-CABLELOK GRIP COMPONENTS
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-17
- Decision date
- 1998-05-05
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LYT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osteonics Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CERAMIC TIPPED SKULL PIN (K040363) | The Jerome Group, Inc. | 2004-04-12 |
| BONE BAND (K983685) | Chapel and Assoc. | 1998-12-04 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.