EARP Interbody System
FDA 510(k) K212477 · Nvision Biomedical Technologies, Inc.
510(k) numberK212477
Submission
- Device name
- EARP Interbody System
- Applicant
- Nvision Biomedical Technologies, Inc.
San Antonio, TX, US - Received
- August 9, 2021
- Decision date
- April 28, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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Questions and answers
When was EARP Interbody System cleared by the FDA?
EARP Interbody System (K212477) received a 510(k) decision of Substantially Equivalent on April 28, 2022, 262 days after the submission was received.
What is the product code of K212477?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.