The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Modification To The Bold Screw.
| Device ID | K011262 |
| 510k Number | K011262 |
| Device Name: | MODIFICATION TO THE BOLD SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | NEWDEAL S.A. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin NEWDEAL S.A. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-25 |
| Decision Date | 2001-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780064398 | K011262 | 000 |