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 |