510(k) K182889
- Device
- KLS Martin Individual Patient Solutions (IPS) Planning System
- Applicant
- KLS-Martin L.P.
- 510(k) number
- K182889
- Product code
- PPT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-26
- Date received
- 2018-10-15
- Regulation
- 882.4310
- Classification name
- Cranial Surgical Planning And Instrument Guides
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jennifer Damato
- Address
- 11201 Saint Johns Industrial Pkwy. S Jacksonville FL US 32246 32246
FDA Registration Numbers#
- 3009555447
- 1057946
- 3014483751
- 1724955
- 3009555440
- 3011724582
- 9610905
- 3005718816
- 3003998208
Source Documents#
Other 510(k) Records For Product Code PPT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | Materialise NV | 2026-01-07 |
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2020-08-31 |
| K151285 | VSP Cranial System | 3D Systems, Inc. | 2016-09-23 |
Legacy Summary#
summary
FDA Review#
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