The following data is part of a premarket notification filed by Otto Bock Orthopedic Industry, Inc. with the FDA for C-leg (3c100).
| Device ID | K991590 |
| 510k Number | K991590 |
| Device Name: | C-LEG (3C100) |
| Classification | Assembly, Knee/shank/ankle/foot, External |
| Applicant | OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth, MN 55441 |
| Contact | John Hendrickson |
| Correspondent | John Hendrickson OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth, MN 55441 |
| Product Code | ISW |
| CFR Regulation Number | 890.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-07 |
| Decision Date | 1999-07-08 |
| Summary: | summary |