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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2018 | Ossur Americas Ossur Skull Pin, Sterile Ceramic Tip Pin,
Part/ Description:
516CS/ Skull Pin 2-1/4in CT Sterl 1PK;
516DS/ Skull Pin 3in CT Sterl 1PK;
517CS/ Skull Pin 2-1/4in CT Sterl 4PK;
517DS/ Skull Pin 3in CT Terminated |
LYT | K040363 |
| Jan 2, 2009 | Ossur Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS Terminated |
LYT | K023959 K040363 |
| Jan 2, 2009 | Ossur Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS Terminated |
LYT | K023959 K040363 |
| Jan 2, 2009 | Ossur Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S Terminated |
LYT | K023959 K040363 |
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