The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Resorbable Mesh Pouch (ballast Mt, Osteoballast Mt).
| Device ID | K200290 |
| 510k Number | K200290 |
| Device Name: | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| 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 | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-05 |
| Decision Date | 2020-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981232153 | K200290 | 000 |
| 10889981232146 | K200290 | 000 |
| 10889981232139 | K200290 | 000 |
| 10889981232122 | K200290 | 000 |