The following data is part of a premarket notification filed by Orthogem Limited with the FDA for Tripore Tdd (ha), Tripore Tdd (bp90), Tripore Tdd (bp15).
| Device ID | K110787 |
| 510k Number | K110787 |
| Device Name: | TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOGEM LIMITED BIOCITY, PENNYFOOT STREET Nottingham, GB Ng1 1gf |
| Contact | We-jen Lo |
| Correspondent | We-jen Lo ORTHOGEM LIMITED BIOCITY, PENNYFOOT STREET Nottingham, GB Ng1 1gf |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-21 |
| Decision Date | 2011-04-21 |
| Summary: | summary |