Product code LYT
- Device name
- Fixation Accessory
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040363 | CERAMIC TIPPED SKULL PIN | The Jerome Group, Inc. | 2004-04-12 |
| K983685 | BONE BAND | Chapel and Assoc. | 1998-12-04 |
| K980594 | OSTEONICS FX-CABLELOK GRIP COMPONENTS | Osteonics Corp. | 1998-05-05 |
| K914812 | K-CAP-E, STERILE | Westcon Orthopedics, Inc. | 1992-01-09 |
| K912762 | K-CAP-I, STERILE | Westcon Orthopedics, Inc. | 1991-07-18 |
| K902053 | K-CAP-I ORTHOPEDIC FIXATION WIRE CAP | Westcon Orthopedics, Inc. | 1990-09-14 |
| K902676 | MICROGUARD, ORTHOPEDIC PIN PROTECTORS | Micro-Aire Surgical Instruments, Inc. | 1990-09-14 |
| K883576 | HORIZON ORTHOPEDIC PIN PROTECTOR | Horizon Medical, Inc. | 1988-09-30 |
| K831072 | JURGAN PIN BALL | Jurgan Development & Mfg., Ltd. | 1983-06-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327036398 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540568168 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540568144 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540568113 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540568106 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540568090 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036497 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036480 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036473 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036466 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036442 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036435 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036428 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036411 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036404 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490264 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036381 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036374 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036367 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036350 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036343 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036336 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327013351 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327013344 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327013337 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327013320 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327013313 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327013306 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490318 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613154490295 | Dall-Miles | Howmedica Osteonics Corp. | 2015-09-24 |