SOLUSTAPLE
Staple, Fixation, Bone
NEWDEAL S.A.
The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Solustaple.
Pre-market Notification Details
| Device ID | K991566 |
| 510k Number | K991566 |
| Device Name: | SOLUSTAPLE |
| Classification | Staple, 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 | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-05 |
| Decision Date | 1999-08-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780052432 | K991566 | 000 |
| 10381780052418 | K991566 | 000 |
| 10381780052395 | K991566 | 000 |
| 10381780052371 | K991566 | 000 |
| M248114025ND1 | K991566 | 000 |
| M248114023ND1 | K991566 | 000 |
| M248114004ND1 | K991566 | 000 |
| M248114002ND1 | K991566 | 000 |
Trademark Results [SOLUSTAPLE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLUSTAPLE 75717451 2610140 Dead/Cancelled |
NEWDEAL 1999-06-01 |
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