Erisma LP Navigated Instruments
510(k) K202956
Erisma LP Navigated Instruments is a Class II device made by Clariance, Sas, cleared under FDA 510(k) K202956 on 26 Feb 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202956 | Date26 Feb 2021 | StatusActive |
Official records
- FDA 510(k) database K202956
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K202956
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701045 | 48701045 | 03700780638314 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701055 | 48701055 | 03700780638307 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701065 | 48701065 | 03700780638291 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701075 | 48701075 | 03700780638284 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701085 | 48701085 | 03700780638277 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701145 | 48701145 | 03700780638260 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701155 | 48701155 | 03700780638352 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701165 | 48701165 | 03700780638253 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701175 | 48701175 | 03700780638239 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48701185 | 48701185 | 03700780638246 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48702001 | 48702001 | 03700780637874 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48710003 | 48710003 | 03700780638222 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48710004 | 48710004 | 03700780638215 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48710005 | 48710005 | 03700780638208 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48731000 | 48731000 | 03700780638185 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 48731001 | 48731001 | 03700780638192 | — | On the market |
| ERISMA® LP_NAVIGATED INSTRUMENTS 99780004 | 99780004 | 03700780638321 | — | On the market |
| Erisma®-LP Navigated 98701045 | 98701045 / 98701045 | 03700780643851 | — | On the market |
| Erisma®-LP Navigated 98701055 | 98701055 / 98701055 | 03700780644148 | — | On the market |
| Erisma®-LP Navigated 98709000 | 98709000 / 98709000 | 03700780644063 | — | On the market |
| Erisma®-LP Navigated 98709001 | 98709001 / 98709001 | 03700780639212 | — | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
- Mako 116171 by MAKO Surgical Corp.
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- Navigation Instruments by GLOBUS MEDICAL, INC.
- Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker by Stryker Corp.
- Stealth™ Spine Clamps; ModuLeX™ Shank Mounts by Medtronic Navigation Inc.