The following data is part of a premarket notification filed by Spinesmith Partners, Llp with the FDA for Solum Iv Bone Void Filler.
| Device ID | K132470 |
| 510k Number | K132470 |
| Device Name: | SOLUM IV BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SPINESMITH PARTNERS, LLP 93 RED RIVER ST. Austin, TX 78701 |
| Contact | Clifton Naivar |
| Correspondent | Clifton Naivar SPINESMITH PARTNERS, LLP 93 RED RIVER ST. Austin, TX 78701 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2014-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817771028764 | K132470 | 000 |
| 00817771028757 | K132470 | 000 |
| 00817771028740 | K132470 | 000 |
| 00817771028733 | K132470 | 000 |
| 00817771028726 | K132470 | 000 |
| 00817371020632 | K132470 | 000 |
| 00817371020625 | K132470 | 000 |
| 00817771028818 | K132470 | 000 |
| 00817771028801 | K132470 | 000 |