Panels › Orthopedic › Product code KWH · Class 2
Prosthesis, Toe, Constrained, Polymer
Regulation 888.3720
0510(k)s in 12 months (21 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KWH
| Company | 510(k)s | Recalls |
|---|---|---|
| Nexa Orthopedics, Inc. | 4 | 0 |
| Dow Corning Corp. Healthcare Industries Materials | 2 | 0 |
| In2bones USA, LLC | 2 | 0 |
| Osteomed Corp. | 2 | 0 |
| Sgarlato Laboratories, Inc. | 2 | 0 |
| Biomedics | 1 | 0 |
| Biomet Manufacturing, Inc. | 1 | 0 |
| Brm Extremities | 1 | 0 |
| Fusion Orthopedics, LLC | 1 | 0 |
| Ortho-Pro, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2010 | Sgarlato Med, LLC Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA Terminated |
KWH | K905795 |
| Nov 24, 2009 | Tornier, Inc. Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 55435.
The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial Terminated |
KWH | K023531 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.