The following data is part of a premarket notification filed by Clariance, Sas with the FDA for Erisma Lp Navigated Instruments.
| Device ID | K202956 |
| 510k Number | K202956 |
| Device Name: | Erisma LP Navigated Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Clariance, SAS 18, Rue Robespierre Beaurains, FR 62217 |
| Contact | Fadwa Bahr |
| Correspondent | Jennifer A. Daudelin M Squared Associates, INC 127 West 30th Street, Floor 9 New York, NY 10001 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-30 |
| Decision Date | 2021-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700780638352 | K202956 | 000 |
| 03700780638215 | K202956 | 000 |
| 03700780638208 | K202956 | 000 |
| 03700780638192 | K202956 | 000 |
| 03700780638185 | K202956 | 000 |
| 03700780637874 | K202956 | 000 |
| 03700780644148 | K202956 | 000 |
| 03700780644063 | K202956 | 000 |
| 03700780643851 | K202956 | 000 |
| 03700780638222 | K202956 | 000 |
| 03700780638239 | K202956 | 000 |
| 03700780638246 | K202956 | 000 |
| 03700780638321 | K202956 | 000 |
| 03700780638314 | K202956 | 000 |
| 03700780638307 | K202956 | 000 |
| 03700780638291 | K202956 | 000 |
| 03700780638284 | K202956 | 000 |
| 03700780638277 | K202956 | 000 |
| 03700780638260 | K202956 | 000 |
| 03700780638253 | K202956 | 000 |
| 03700780639212 | K202956 | 000 |