HIP SEXTANT INSTRUMENT SYSTEM
FDA 510(k) clearance K093491 · decided 2010-12-09
Clearance details
- K-number
- K093491
- Device name
- HIP SEXTANT INSTRUMENT SYSTEM
- Applicant
- Surgical Planning Associates
- Decision
- Substantially Equivalent
- Date received
- 2009-11-10
- Decision date
- 2010-12-09
- Days to decision
- 394 days
- Clearance type
- Traditional
- Product code
- OSF
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Medford, MA, 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 |
|---|---|---|
| HipXpert and HipInsight System (K233315) | Surgical Planning Associates, Inc. | 2024-08-08 |
| HipXpert 3D Display and Anchoring Application (K200384) | Surgical Planning Associates, Inc. | 2021-01-28 |
Recalls involving this device
No recalls on record reference this clearance.