The following data is part of a premarket notification filed by Doctors Research Group, Inc. with the FDA for Kryptonite Bone Cement.
| Device ID | K091382 |
| 510k Number | K091382 |
| Device Name: | KRYPTONITE BONE CEMENT |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | DOCTORS RESEARCH GROUP, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton DOCTORS RESEARCH GROUP, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-11 |
| Decision Date | 2009-11-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() KRYPTONITE BONE CEMENT 76479155 3107197 Dead/Cancelled |
Doctors Research Group 2002-12-26 |