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 |