The following data is part of a premarket notification filed by Matrix Surgical Holdings, Llc/matrix Surgical Usa with the FDA for Omnipore Duromax Surgical Implants.
| Device ID | K180249 |
| 510k Number | K180249 |
| Device Name: | OmniPore DUROMAX Surgical Implants |
| Classification | Plate, Bone |
| Applicant | Matrix Surgical Holdings, LLC/Matrix Surgical USA 4025 Welcome All Road Suite 120 Atlanta, GA 30349 |
| Contact | John O'shaughnessy |
| Correspondent | Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Dr Alpharetta, GA 30004 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-29 |
| Decision Date | 2018-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852578008144 | K180249 | 000 |
| 00852578008137 | K180249 | 000 |
| 00852578008120 | K180249 | 000 |
| 00852578008113 | K180249 | 000 |
| 00852578008106 | K180249 | 000 |