The following data is part of a premarket notification filed by Neosteo with the FDA for Superelastic Staple.
| Device ID | K192447 |
| 510k Number | K192447 |
| Device Name: | Superelastic Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | Neosteo Malleve 2A, 1 Boulevard Jean Moulin Nantes, FR 44 100 |
| Contact | Anne-cecile Grandremy |
| Correspondent | J.d Webb The OrthoMedix Group, Inc. 4313 W. 3800 S West Haven, UT 84401 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-06 |
| Decision Date | 2020-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701173705507 | K192447 | 000 |
| 03701173703664 | K192447 | 000 |
| 03701173703671 | K192447 | 000 |
| 03701173703688 | K192447 | 000 |
| 03701173703695 | K192447 | 000 |
| 03701173703701 | K192447 | 000 |
| 03701173703718 | K192447 | 000 |
| 03701173703725 | K192447 | 000 |
| 03701173703732 | K192447 | 000 |
| 03701173703749 | K192447 | 000 |
| 03701173703756 | K192447 | 000 |
| 03701173703763 | K192447 | 000 |
| 03701173703770 | K192447 | 000 |
| 03701173705460 | K192447 | 000 |
| 03701173705477 | K192447 | 000 |
| 03701173705484 | K192447 | 000 |
| 03701173705491 | K192447 | 000 |
| 03701173703657 | K192447 | 000 |