The following data is part of a premarket notification filed by Osteopore, Inc. with the FDA for Osteopore Pcl Scaffold.
| Device ID | K051093 |
| 510k Number | K051093 |
| Device Name: | OSTEOPORE PCL SCAFFOLD |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | OSTEOPORE, INC. 958 KRISTIN RIDGE WAY Milpitas, CA 95035 |
| Contact | Alexander Yeo |
| Correspondent | Alexander Yeo OSTEOPORE, INC. 958 KRISTIN RIDGE WAY Milpitas, CA 95035 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-28 |
| Decision Date | 2006-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08885013200126 | K051093 | 000 |
| 08885013200546 | K051093 | 000 |
| 08885013200508 | K051093 | 000 |
| 08885013200485 | K051093 | 000 |
| 08885013200478 | K051093 | 000 |
| 08885013200409 | K051093 | 000 |
| 08885013200195 | K051093 | 000 |
| 08885013200140 | K051093 | 000 |
| 08885013200041 | K051093 | 000 |
| 08885013201338 | K051093 | 000 |
| 08885013201321 | K051093 | 000 |
| 08885013200133 | K051093 | 000 |
| 08885013201314 | K051093 | 000 |
| 08885013200577 | K051093 | 000 |
| 08885013201239 | K051093 | 000 |
| 08885013201352 | K051093 | 000 |
| 08885013200119 | K051093 | 000 |
| 08885013201970 | K051093 | 000 |
| 08885013201963 | K051093 | 000 |
| 08885013201956 | K051093 | 000 |
| 08885013201949 | K051093 | 000 |
| 08885013201925 | K051093 | 000 |
| 08885013201871 | K051093 | 000 |
| 08885013201864 | K051093 | 000 |
| 08885013201840 | K051093 | 000 |
| 08885013201390 | K051093 | 000 |
| 08885013201383 | K051093 | 000 |
| 08885013201376 | K051093 | 000 |
| 08885013201307 | K051093 | 000 |