The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Discectomy Navigation Ready Instruments And Universal Navigation Adaptor Set.
Device ID | K212756 |
510k Number | K212756 |
Device Name: | Discectomy Navigation Ready Instruments And Universal Navigation Adaptor Set |
Classification | Orthopedic Stereotaxic Instrument |
Applicant | MEDOS International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
Contact | Nicole Aeschbacher |
Correspondent | Nicole Aeschbacher MEDOS International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
Product Code | OLO |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-31 |
Decision Date | 2022-05-05 |