The following data is part of a premarket notification filed by The Implantech Inc./shefabone with the FDA for Shefabone Scpc Resorbable Bone Graft.
| Device ID | K153230 |
| 510k Number | K153230 |
| Device Name: | ShefaBone SCPC Resorbable Bone Graft |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | THE IMPLANTECH INC./SHEFABONE 9016 CLIFF CAMERON DR., #201 Charlotte, NC 28269 |
| Contact | Ahmed El-ghannam |
| Correspondent | Elaine Duncan PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-06 |
| Decision Date | 2016-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060517850005 | K153230 | 000 |