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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 the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2017-02-01 under 510(k) 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. The listed applicant is Life Spine, Inc.. The 510(k) number is K161279.

When did Life Spine Metatarsal Hemi Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for Life Spine Metatarsal Hemi Implant?

The FDA 510(k) record lists Life Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Life Spine, Inc. as applicant

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Related Devices (Code: KWD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great 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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