The following data is part of a premarket notification filed by Matrix Surgical Holdings, Llc/matrix Surgical Usa with the FDA for Omnipore Customized Surgical Implants.
| Device ID | K133046 |
| 510k Number | K133046 |
| Device Name: | OMNIPORE CUSTOMIZED SURGICAL IMPLANTS |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA 111 LAUREL RIDGE DR. Alpharetta, GA 30004 |
| Contact | Julie Stephens |
| Correspondent | Julie Stephens MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA 111 LAUREL RIDGE DR. Alpharetta, GA 30004 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2014-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855421005420 | K133046 | 000 |
| 00855421005413 | K133046 | 000 |
| 00855421005406 | K133046 | 000 |
| 00852578008151 | K133046 | 000 |