EARP Interbody System
by Nvision Biomedical Technologies, Inc
510(k) K212477
EARP Interbody System is a Class II device made by Nvision Biomedical Technologies, Inc, cleared under FDA 510(k) K212477 on 28 Apr 2022, 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 | NumberK212477 | Date28 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K212477
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- FDA applicant
- Nvision Biomedical Technologies, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K212477
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 | |||
|---|---|---|---|---|
| EARP Interbody System EARP1425-0008 | EARP1425-0008 | 00810135960007 | Depth 14 mm; Width 25 mm; Height 8 mm | No longer on the market |
Similar devices
Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).
- JULIET ® Ti LL JLT-S0 40 12-S by Spineart
- Atlas Spine Project X Expandable Posterior Lumbar Interbody System by ATLAS SPINE INC.
- JULIET ® Ti LL JLT-M0 60 10-S by Spineart
- CAPSTONE R SPINAL SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
- ARTFX Lumbar PEEK Cages by ARTFX MEDICAL LLC
- ShurFit Lumbar Interbody System by Precision Spine, Inc.
- INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE by Vertebral Technologies, Inc.
- CLYDESDALE SPINAL SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
- restor3d TIDAL Lumbar Interbody Fusion System by Restor3D
- LATIS SPACER by GLOBUS MEDICAL, INC.