The following data is part of a premarket notification filed by Synthes Usa Products Llc with the FDA for Norian Reinforced, Norian Reinforced Fast Set Putty.
| Device ID | K102018 |
| 510k Number | K102018 |
| Device Name: | NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | SYNTHES USA PRODUCTS LLC 1230 WILSON DRIVE West Chester, PA 19380 |
| Contact | Jeffrey L Dow |
| Correspondent | Jeffrey L Dow SYNTHES USA PRODUCTS LLC 1230 WILSON DRIVE West Chester, PA 19380 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-19 |
| Decision Date | 2010-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9806161001S0 | K102018 | 000 |
| H9806160501S0 | K102018 | 000 |
| H9806160301S0 | K102018 | 000 |
| H9806151001S0 | K102018 | 000 |
| H9806150501S0 | K102018 | 000 |
| H9806150301S0 | K102018 | 000 |