510(k) K101030 ยท HWC Screw, Fixation, Bone
MODIFICATION TO HBS HEADLESS BONE SCREW
| Applicant | Biopro, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, Jun 3, 2010 |
| Received | Apr 13, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2019 | BioPro, Inc. K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not Terminated |
NBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.