The following data is part of a premarket notification filed by Seaspine Corporation with the FDA for Dry Dbm- A Putty.
| Device ID | K212135 |
| 510k Number | K212135 |
| Device Name: | Dry DBM- A Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SeaSpine Corporation 2 Goodyear Irvine, CA 92618 |
| Contact | Caryn Sailor |
| Correspondent | Caryn Sailor SeaSpine Corporation 2 Goodyear Irvine, CA 92618 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-08 |
| Decision Date | 2021-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981283964 | K212135 | 000 |
| 10889981283834 | K212135 | 000 |
| 10889981283827 | K212135 | 000 |
| 10889981283810 | K212135 | 000 |
| 10889981284107 | K212135 | 000 |
| 10889981284091 | K212135 | 000 |
| 10889981284084 | K212135 | 000 |
| 10889981284077 | K212135 | 000 |
| 10889981284060 | K212135 | 000 |
| 10889981284053 | K212135 | 000 |
| 10889981284046 | K212135 | 000 |
| 10889981283841 | K212135 | 000 |
| 10889981283858 | K212135 | 000 |
| 10889981283957 | K212135 | 000 |
| 10889981283940 | K212135 | 000 |
| 10889981283933 | K212135 | 000 |
| 10889981283926 | K212135 | 000 |
| 10889981283919 | K212135 | 000 |
| 10889981283902 | K212135 | 000 |
| 10889981283896 | K212135 | 000 |
| 10889981283889 | K212135 | 000 |
| 10889981283872 | K212135 | 000 |
| 10889981283865 | K212135 | 000 |
| 10889981284039 | K212135 | 000 |