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FDA 510(k)

IMPLANET SPINE SYSTEM

K-Number: K132303 · 2013-10-10

ApplicantImplanet, S.A.
Decision Date2013-10-10
Product CodeOSH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPLANET SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implanet, S.A.. It received FDA 510(k) clearance on 2013-10-10 under 510(k) number K132303. The device is classified under product code OSH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANET SPINE SYSTEM?

IMPLANET SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-10. The listed applicant is Implanet, S.A.. The 510(k) number is K132303.

When did IMPLANET SPINE SYSTEM receive FDA 510(k) clearance?

IMPLANET SPINE SYSTEM received FDA 510(k) clearance on 2013-10-10, under 510(k) number K132303.

Who is the listed applicant for IMPLANET SPINE SYSTEM?

The FDA 510(k) record lists Implanet, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANET SPINE SYSTEM?

The FDA product code for IMPLANET SPINE SYSTEM is OSH.

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Other records listing Implanet, S.A. as applicant

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Related Devices (Code: OSH)

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.

K153446OLYMPIC Posterior Spinal Fixation SystemAstura MedicalK132574PASS LP SPINAL SYSTEMMedicrea InternationalK132575PASS LP SPINAL SYSTEMMedicrea InternationalK131802EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEMDepuy Spine, A Johnson & Johnson CompanyK131615POLARIS SPINAL SYSTEMBiomet Spine (Aka Ebi, LLC)K131784RANGE SPINAL SYSTEMK2m, Inc.

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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