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FDA 510(k)

RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS

K-Number: K123412 · 2013-02-13

ApplicantK2m, Inc.
Decision Date2013-02-13
Product CodeOSH
Advisory CommitteeOR
DecisionUnknown

Device Summary

RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2013-02-13 under 510(k) number K123412. The device is classified under product code OSH. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS?

RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS is a medical device that received FDA 510(k) clearance on 2013-02-13. The listed applicant is K2m, Inc.. The 510(k) number is K123412.

When did RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS receive FDA 510(k) clearance?

RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS received FDA 510(k) clearance on 2013-02-13, under 510(k) number K123412.

Who is the listed applicant for RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS?

The FDA product code for RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS is OSH.

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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 InternationalK132303IMPLANET SPINE SYSTEMImplanet, S.A.K132575PASS LP SPINAL SYSTEMMedicrea InternationalK131802EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEMDepuy Spine, A Johnson & Johnson CompanyK131615POLARIS SPINAL SYSTEMBiomet Spine (Aka Ebi, 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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