K'FIX
FDA 510(k) clearance K010847 · decided 2001-06-19
Clearance details
- K-number
- K010847
- Device name
- K'FIX
- Applicant
- Avanta Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-21
- Decision date
- 2001-06-19
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NDL
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Avanta Orthopaedics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TBW (K010545) | Tri-Med, Inc. | 2001-06-06 |
Recalls involving this device
No recalls on record reference this clearance.