The following data is part of a premarket notification filed by Orthogem Limited with the FDA for Tripore, Models Ha, Bp90, Bp15.
| Device ID | K070132 |
| 510k Number | K070132 |
| Device Name: | TRIPORE, MODELS HA, BP90, BP15 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOGEM LIMITED BIOCITY, PENNYFOOT STREET Nottingham, Notts, GB Ng1 1gf |
| Contact | Rod Ruston |
| Correspondent | Rod Ruston ORTHOGEM LIMITED BIOCITY, PENNYFOOT STREET Nottingham, Notts, GB Ng1 1gf |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051775000721 | K070132 | 000 |
| 05051775000486 | K070132 | 000 |
| 05051775000479 | K070132 | 000 |
| 05051775000462 | K070132 | 000 |
| 05051775000455 | K070132 | 000 |
| 05051775000448 | K070132 | 000 |
| 05051775000431 | K070132 | 000 |
| 05051775000424 | K070132 | 000 |
| 05051775000417 | K070132 | 000 |
| 05051775000400 | K070132 | 000 |
| 05051775000394 | K070132 | 000 |
| 05051775000387 | K070132 | 000 |
| 05051775000370 | K070132 | 000 |
| 05051775000363 | K070132 | 000 |
| 05051775000356 | K070132 | 000 |
| 05051775000349 | K070132 | 000 |
| 05051775000332 | K070132 | 000 |
| 05051775000325 | K070132 | 000 |
| 05051775000493 | K070132 | 000 |
| 05051775000509 | K070132 | 000 |
| 05051775000714 | K070132 | 000 |
| 05051775000707 | K070132 | 000 |
| 05051775000691 | K070132 | 000 |
| 05051775000684 | K070132 | 000 |
| 05051775000677 | K070132 | 000 |
| 05051775000660 | K070132 | 000 |
| 05051775000653 | K070132 | 000 |
| 05051775000646 | K070132 | 000 |
| 05051775000639 | K070132 | 000 |
| 05051775000622 | K070132 | 000 |
| 05051775000615 | K070132 | 000 |
| 05051775000608 | K070132 | 000 |
| 05051775000592 | K070132 | 000 |
| 05051775000547 | K070132 | 000 |
| 05051775000530 | K070132 | 000 |
| 05051775000523 | K070132 | 000 |
| 05051775000516 | K070132 | 000 |
| 05051775000318 | K070132 | 000 |