510(k) K991590 ยท ISW Assembly, Knee/Shank/Ankle/Foot, External
C-LEG (3C100)
| Applicant | Otto Bock Orthopedic Industry, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jul 8, 1999 |
| Received | May 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991590
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2007 | Bock,Otto,Orthopedic Ind,Inc Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint u Terminated |
KFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.