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FDA 510(k)

PASS LP SPINAL SYSTEM

K-Number: K132575 · 2013-10-03

ApplicantMedicrea International
Decision Date2013-10-03
Product CodeOSH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASS LP SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International. It received FDA 510(k) clearance on 2013-10-03 under 510(k) number K132575. 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 PASS LP SPINAL SYSTEM?

PASS LP SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Medicrea International. The 510(k) number is K132575.

When did PASS LP SPINAL SYSTEM receive FDA 510(k) clearance?

PASS LP SPINAL SYSTEM received FDA 510(k) clearance on 2013-10-03, under 510(k) number K132575.

Who is the listed applicant for PASS LP SPINAL SYSTEM?

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

What is the FDA product code for PASS LP SPINAL SYSTEM?

The FDA product code for PASS LP SPINAL SYSTEM is OSH.

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Other records listing Medicrea International as applicant

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.

K220810Infinity™ OCT System and PASS OCT Spinal SystemK220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemK180091UNiD Spine AnalyzerK170172UNiD Spine AnalyzerK153169PASS OCT Patient Specific RodsK132395LIGAPASS

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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.K131802EXPEDIUM, 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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