HipXpert 3D Display and Anchoring Application
FDA 510(k) clearance K200384 · decided 2021-01-28
Clearance details
- K-number
- K200384
- Device name
- HipXpert 3D Display and Anchoring Application
- Applicant
- Surgical Planning Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-18
- Decision date
- 2021-01-28
- Days to decision
- 345 days
- Clearance type
- Traditional
- Product code
- OSF
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Boston, 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 |
| HIP SEXTANT INSTRUMENT SYSTEM (K093491) | Surgical Planning Associates | 2010-12-09 |
Recalls involving this device
No recalls on record reference this clearance.