IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
FDA 510(k) K173080 · Huvexel Co. , Ltd.
510(k) numberK173080
Submission
- Device name
- IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
- Applicant
- Huvexel Co. , Ltd.
Seongnam-Si, KR - Received
- September 29, 2017
- Decision date
- October 31, 2017
- 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 IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) cleared by the FDA?
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080) received a 510(k) decision of Substantially Equivalent on October 31, 2017, 32 days after the submission was received.
What is the product code of K173080?
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.