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FDA 510(k)

OP SPINE SYSTEM

K-Number: K120291 · 2012-04-16

ApplicantOrthoPediatrics Corp.
Decision Date2012-04-16
Product CodeOSH
Advisory CommitteeOR
DecisionUnknown

Device Summary

OP SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2012-04-16 under 510(k) number K120291. 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 OP SPINE SYSTEM?

OP SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-16. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K120291.

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

OP SPINE SYSTEM received FDA 510(k) clearance on 2012-04-16, under 510(k) number K120291.

Who is the listed applicant for OP SPINE SYSTEM?

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

What is the FDA product code for OP SPINE SYSTEM?

The FDA product code for OP SPINE SYSTEM is OSH.

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Other records listing OrthoPediatrics Corp. 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 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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