nva, nvp, and nvt
FDA 510(k) K162426 · Nvision Biomedical Technologies, LLC
510(k) numberK162426
Submission
- Device name
- nva, nvp, and nvt
- Applicant
- Nvision Biomedical Technologies, LLC
San Antonio, TX, US - Received
- August 30, 2016
- Decision date
- September 29, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 nva, nvp, and nvt cleared by the FDA?
nva, nvp, and nvt (K162426) received a 510(k) decision of Substantially Equivalent on September 29, 2016, 30 days after the submission was received.
What is the product code of K162426?
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.