C-LEG (3C100)
FDA 510(k) clearance K991590 · decided 1999-07-08
Clearance details
- K-number
- K991590
- Device name
- C-LEG (3C100)
- Applicant
- Otto Bock Orthopedic Industry, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-07
- Decision date
- 1999-07-08
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- ISW
- Device class
- 2
- Regulation number
- 890.3500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for recall (Z-0363-2007) | Bock,Otto,Orthopedic Ind,Inc | 2007-01-25 |