KLS Martin Individual Patient Solutions (IPS) Planning System
FDA 510(k) clearance K201052 · decided 2020-08-31
Clearance details
- K-number
- K201052
- Device name
- KLS Martin Individual Patient Solutions (IPS) Planning System
- Applicant
- KLS-Martin L.P.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-21
- Decision date
- 2020-08-31
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- PPT
- Device class
- 2
- Regulation number
- 882.4310
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Jacksonville, FL, 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 |
|---|---|---|
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (K253308) | Materialise NV | 2026-01-07 |
| KLS Martin Individual Patient Solutions (IPS) Planning System (K182889) | KLS-Martin L.P. | 2019-07-26 |
| VSP Cranial System (K151285) | 3D Systems, Inc. | 2016-09-23 |
Recalls involving this device
No recalls on record reference this clearance.