The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Resorbable Mesh Device.
| Device ID | K193040 |
| 510k Number | K193040 |
| Device Name: | Resorbable Mesh Device |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SeaSpine Orthopedics Corporation 2 Goodyear Irvine, CA 92618 |
| Contact | Caryn Sailor |
| Correspondent | Caryn Sailor SeaSpine Orthopedics Corporation 2 Goodyear Irvine, CA 92618 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-31 |
| Decision Date | 2019-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981189266 | K193040 | 000 |
| 10889981189259 | K193040 | 000 |