The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Resorbable Mesh Device.
| Device ID | K172130 |
| 510k Number | K172130 |
| Device Name: | Resorbable Mesh Device |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SeaSpine Orthopedics Corporation 2 Goodyear Irvine, CA 92618 |
| Contact | Jenny Fam |
| Correspondent | Caryn Sailor SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 98008 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-14 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981149376 | K172130 | 000 |
| 10889981149369 | K172130 | 000 |
| 10889981149352 | K172130 | 000 |
| 10889981149345 | K172130 | 000 |
| 10889981149338 | K172130 | 000 |
| 10889981149321 | K172130 | 000 |
| 10889981149314 | K172130 | 000 |
| 10889981149307 | K172130 | 000 |