The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Drillable.
| Device ID | K073303 |
| 510k Number | K073303 |
| Device Name: | NORIAN DRILLABLE |
| Classification | Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation |
| Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Jeffrey L Dow |
| Correspondent | Jeffrey L Dow SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | OIS |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-23 |
| Decision Date | 2008-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67907704110S0 | K073303 | 000 |
| H67907704105S0 | K073303 | 000 |
| H67907704103S0 | K073303 | 000 |
| H67907704010S0 | K073303 | 000 |
| H67907704005S0 | K073303 | 000 |
| H67907704003S0 | K073303 | 000 |