Panels › Orthopedic › Product code LYT · Class 2
Fixation Accessory
Regulation 888.3030
0510(k)s in 12 months (9 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in LYT
| Company | 510(k)s | Recalls |
|---|---|---|
| Ossur | 0 | 3 |
| Westcon Orthopedics, Inc. | 3 | 0 |
| Chapel and Assoc. | 1 | 0 |
| Horizon Medical, Inc. | 1 | 0 |
| The Jerome Group, Inc. | 1 | 0 |
| Jurgan Development & Mfg., Ltd. | 1 | 0 |
| Micro-Aire Surgical Instruments, Inc. | 1 | 0 |
| Ossur Americas | 0 | 1 |
| Osteonics Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 2004 | K040363 | CERAMIC TIPPED SKULL PIN The Jerome Group, Inc. | LYT |
| Dec 4, 1998 | K983685 | BONE BAND Chapel and Assoc. | LYT |
| May 5, 1998 | K980594 | OSTEONICS FX-CABLELOK GRIP COMPONENTS Osteonics Corp. | LYT |
| Jan 9, 1992 | K914812 | K-CAP-E, STERILE Westcon Orthopedics, Inc. | LYT |
| Jul 18, 1991 | K912762 | K-CAP-I, STERILE Westcon Orthopedics, Inc. | LYT |
| Sep 14, 1990 | K902676 | MICROGUARD, ORTHOPEDIC PIN PROTECTORS Micro-Aire Surgical Instruments, Inc. | LYT |
| Sep 14, 1990 | K902053 | K-CAP-I ORTHOPEDIC FIXATION WIRE CAP Westcon Orthopedics, Inc. | LYT |
| Sep 30, 1988 | K883576 | HORIZON ORTHOPEDIC PIN PROTECTOR Horizon Medical, Inc. | LYT |
| Jun 8, 1983 | K831072 | JURGAN PIN BALL Jurgan Development & Mfg., Ltd. | LYT |
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