The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for The Uni-clip Staple.
| Device ID | K011716 |
| 510k Number | K011716 |
| Device Name: | THE UNI-CLIP STAPLE |
| 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 | 2001-06-04 |
| Decision Date | 2001-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780052777 | K011716 | 000 |
| M248213512ND1 | K011716 | 000 |
| 10381780052722 | K011716 | 000 |
| 10381780052708 | K011716 | 000 |
| 10381780052685 | K011716 | 000 |
| M248213314ND1 | K011716 | 000 |
| M248213313ND1 | K011716 | 000 |
| 10381780052623 | K011716 | 000 |
| 10381780052609 | K011716 | 000 |
| M248213215ND1 | K011716 | 000 |
| M248213214ND1 | K011716 | 000 |
| M248213213ND1 | K011716 | 000 |
| 10381780052524 | K011716 | 000 |
| M248213116ND1 | K011716 | 000 |
| M248213115ND1 | K011716 | 000 |
| M248213114ND1 | K011716 | 000 |
| 10381780052760 | K011716 | 000 |
| 10381780052456 | K011716 | 000 |
| 10381780052753 | K011716 | 000 |
| 10381780052739 | K011716 | 000 |
| 10381780052715 | K011716 | 000 |
| 10381780052692 | K011716 | 000 |
| 10381780052678 | K011716 | 000 |
| 10381780052654 | K011716 | 000 |
| 10381780052630 | K011716 | 000 |
| 10381780052616 | K011716 | 000 |
| 10381780052593 | K011716 | 000 |
| 10381780052579 | K011716 | 000 |
| 10381780052555 | K011716 | 000 |
| 10381780052531 | K011716 | 000 |
| 10381780052517 | K011716 | 000 |
| 10381780052494 | K011716 | 000 |
| 10381780052470 | K011716 | 000 |
| M248213113ND1 | K011716 | 000 |