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 |