ACTAEON PROBE
FDA 510(k) clearance K013429 · decided 2002-01-11
Clearance details
- K-number
- K013429
- Device name
- ACTAEON PROBE
- Applicant
- Osteobiologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-16
- Decision date
- 2002-01-11
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- NGR
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE (K010303) | Artscan Medical Innovations | 2001-09-11 |
Recalls involving this device
No recalls on record reference this clearance.