The following data is part of a premarket notification filed by Synthes Usa Products Llc with the FDA for Norian Drillable Inject, Norian Drillable Fast Set Putty.
| Device ID | K102722 |
| 510k Number | K102722 |
| Device Name: | NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SYNTHES USA PRODUCTS LLC 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Jeffrey L Dow, Jd |
| Correspondent | Jeffrey L Dow, Jd SYNTHES USA PRODUCTS LLC 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-21 |
| Decision Date | 2011-01-27 |
| Summary: | summary |