The following data is part of a premarket notification filed by Fibralign Corporation with the FDA for Biobridge Collagen Matrix.
| Device ID | K151083 |
| 510k Number | K151083 |
| Device Name: | BioBridge Collagen Matrix |
| Classification | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| Applicant | Fibralign Corporation 32930 Alvarado-Niles Road, Suite 350 Union City, CA 94587 |
| Contact | Greg King |
| Correspondent | Ronald S Warren EXPERIEN GROUP, LLC 755 N. MATHILDA AVENUE SUITE 100 Sunnyvale, CA 94085 |
| Product Code | OWY |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-22 |
| Decision Date | 2016-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B218PRT0070 | K151083 | 000 |