The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Connexus, .5cc, Model 023000-005.
| Device ID | K052098 |
| 510k Number | K052098 |
| Device Name: | CONNEXUS, .5CC, MODEL 023000-005 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Contact | Paul Doner |
| Correspondent | Paul Doner ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-03 |
| Decision Date | 2005-09-07 |
| Summary: | summary |