CERAMIC TIPPED SKULL PIN
FDA 510(k) clearance K040363 · decided 2004-04-12
Clearance details
- K-number
- K040363
- Device name
- CERAMIC TIPPED SKULL PIN
- Applicant
- The Jerome Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-13
- Decision date
- 2004-04-12
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- LYT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Moorestown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S recall (Z-0594-2009) | Ossur | 2009-01-02 |
| Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS recall (Z-0595-2009) | Ossur | 2009-01-02 |
| Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS recall (Z-0596-2009) | Ossur | 2009-01-02 |