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FDA 510(k)

Life Spine Metatarsal Hemi Implant

K-Number: K161279 · 2017-02-01

ApplicantLife Spine, Inc.
Decision Date2017-02-01
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Life Spine Metatarsal Hemi Implant is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2017-02-01 under approval number K161279. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Life Spine Metatarsal Hemi Implant?

Life Spine Metatarsal Hemi Implant is a medical device that received FDA 510(k) clearance on 2017-02-01. It is manufactured by Life Spine, Inc.. The 510(k) number is K161279.

When was Life Spine Metatarsal Hemi Implant approved by the FDA?

Life Spine Metatarsal Hemi Implant received FDA 510(k) clearance on 2017-02-01, under approval number K161279.

What company makes Life Spine Metatarsal Hemi Implant?

Life Spine Metatarsal Hemi Implant is manufactured by Life Spine, Inc..

What is the FDA product code for Life Spine Metatarsal Hemi Implant?

The FDA product code for Life Spine Metatarsal Hemi Implant is KWD.

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Related PubMed Literature

PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (2026) PMID: 33778409 Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices. JOR spine (2021) PMID: 26056630 Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment. International journal of spine surgery (2015)

Other Devices by Life Spine, Inc.

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Related Devices (Code: KWD)

K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. K190261BOSS Toe Fixation SystemArthrosurface, Inc. K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc. K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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