ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
FDA 510(k) clearance K010303 · decided 2001-09-11
Clearance details
- K-number
- K010303
- Device name
- ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
- Applicant
- Artscan Medical Innovations
- Decision
- Substantially Equivalent
- Date received
- 2000-12-05
- Decision date
- 2001-09-11
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- NGR
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Akron, OH, 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 |
|---|---|---|
| ACTAEON PROBE (K013429) | Osteobiologics, Inc. | 2002-01-11 |
Recalls involving this device
No recalls on record reference this clearance.