The following data is part of a premarket notification filed by Novastep with the FDA for Airlock Centrolock Osteosynthesis Implant System.
| Device ID | K192356 |
| 510k Number | K192356 |
| Device Name: | Airlock Centrolock Osteosynthesis Implant System |
| Classification | Plate, Fixation, Bone |
| Applicant | NOVASTEP Espace Performance III- Batiment P Saint-gregoire, FR 35769 |
| Contact | Gilles Audic |
| Correspondent | Gilles Audic NOVASTEP Espace Performance III- Batiment P Saint-gregoire, FR 35769 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-29 |
| Decision Date | 2019-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700879512327 | K192356 | 000 |
| 03700879511863 | K192356 | 000 |
| 03700879511856 | K192356 | 000 |
| 03700879511849 | K192356 | 000 |
| 03700879511832 | K192356 | 000 |
| 03700879511825 | K192356 | 000 |
| 03700879511818 | K192356 | 000 |
| 03700879511801 | K192356 | 000 |
| 03700879511795 | K192356 | 000 |
| 03700879511788 | K192356 | 000 |
| 03700879511771 | K192356 | 000 |
| 03700879511757 | K192356 | 000 |
| 03700879511696 | K192356 | 000 |
| 03700879516028 | K192356 | 000 |
| 03700879516011 | K192356 | 000 |
| 03700879513973 | K192356 | 000 |
| 03700879511870 | K192356 | 000 |
| 03700879511887 | K192356 | 000 |
| 03700879511894 | K192356 | 000 |
| 03700879512310 | K192356 | 000 |
| 03700879512303 | K192356 | 000 |
| 03700879512020 | K192356 | 000 |
| 03700879512013 | K192356 | 000 |
| 03700879512006 | K192356 | 000 |
| 03700879511993 | K192356 | 000 |
| 03700879511986 | K192356 | 000 |
| 03700879511979 | K192356 | 000 |
| 03700879511962 | K192356 | 000 |
| 03700879511955 | K192356 | 000 |
| 03700879511948 | K192356 | 000 |
| 03700879511931 | K192356 | 000 |
| 03700879511924 | K192356 | 000 |
| 03700879511917 | K192356 | 000 |
| 03700879511900 | K192356 | 000 |
| 03700879513966 | K192356 | 000 |