510(k) K073303
- Device
- NORIAN DRILLABLE
- Applicant
- SYNTHES (USA)
- 510(k) number
- K073303
- Product code
- OIS
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2008-07-02
- Date received
- 2007-11-23
- Regulation
- 888.3045
- Classification name
- Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFREY L DOW
- Address
- 1230 Wilson Dr. West Chester PA US 19380 19380
FDA Registration Numbers#
- 3008812560
- 3012447612
- 3016050940
- 3003477135
- 3005972619
- 3004464325
- 3012329552
- 1319639
- 2530154
- 3009417901
- 3008868758
- 2245304
- 3008522639
Source Documents#
Legacy Summary#
summary
FDA Review#
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