The following data is part of a premarket notification filed by Oriental Resources Development Limited with the FDA for Nuros Bone Graft Substitute.
| Device ID | K140913 |
| 510k Number | K140913 |
| Device Name: | NUROS BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORIENTAL RESOURCES DEVELOPMENT LIMITED NO.45 MINSHENG ROAD DANSHUI TOWN New Taipei City, TW 251 |
| Contact | Michael Lee |
| Correspondent | Michael Lee ORIENTAL RESOURCES DEVELOPMENT LIMITED NO.45 MINSHENG ROAD DANSHUI TOWN New Taipei City, TW 251 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-10 |
| Decision Date | 2015-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04716329941400 | K140913 | 000 |
| 04716329941141 | K140913 | 000 |