The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Plexur-p.
| Device ID | K080511 |
| 510k Number | K080511 |
| Device Name: | PLEXUR-P |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Chris Talbot |
| Correspondent | Chris Talbot OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169218307 | K080511 | 000 |
| 00643169218086 | K080511 | 000 |
| 00643169218093 | K080511 | 000 |
| 00643169218109 | K080511 | 000 |
| 00643169218116 | K080511 | 000 |
| 00643169218123 | K080511 | 000 |
| 00643169218130 | K080511 | 000 |
| 00643169218147 | K080511 | 000 |
| 00643169218161 | K080511 | 000 |
| 00643169218185 | K080511 | 000 |
| 00643169218208 | K080511 | 000 |
| 00643169218222 | K080511 | 000 |
| 00643169218239 | K080511 | 000 |
| 00643169218246 | K080511 | 000 |
| 00643169218253 | K080511 | 000 |
| 00643169218260 | K080511 | 000 |
| 00643169218277 | K080511 | 000 |
| 00643169218284 | K080511 | 000 |
| 00643169218062 | K080511 | 000 |