The following data is part of a premarket notification filed by Orthogem Ltd with the FDA for Synthetic Bone Graft (tripore Ha, Tripore Bp90, Tripore Bp15).
| Device ID | K150064 |
| 510k Number | K150064 |
| Device Name: | Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOGEM LTD BIOCITY, PENNYFOOT STREET Nottingham, GB Ng1 1gf |
| Contact | Paul Z Markgraf |
| Correspondent | Rod Ruston PRIORY ANALYSTS LTD 15 RUDCHESTERS Milton Keynes, GB Mk13 0ph |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-13 |
| Decision Date | 2015-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051775000868 | K150064 | 000 |
| 05051775000288 | K150064 | 000 |
| 05051775000738 | K150064 | 000 |
| 05051775000745 | K150064 | 000 |
| 05051775000752 | K150064 | 000 |
| 05051775000769 | K150064 | 000 |
| 05051775000776 | K150064 | 000 |
| 05051775000783 | K150064 | 000 |
| 05051775000790 | K150064 | 000 |
| 05051775000806 | K150064 | 000 |
| 05051775000813 | K150064 | 000 |
| 05051775000820 | K150064 | 000 |
| 05051775000837 | K150064 | 000 |
| 05051775000844 | K150064 | 000 |
| 05051775000851 | K150064 | 000 |
| 05051775000271 | K150064 | 000 |