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FDA 510(k)

PASS LP SPINAL SYSTEM

K-Number: K083810 · 2009-07-31

ApplicantMedicrea Technologies
Decision Date2009-07-31
Product CodeMNI
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 Technologies. It received FDA 510(k) clearance on 2009-07-31 under 510(k) number K083810. The device is classified under product code MNI. 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 2009-07-31. The listed applicant is Medicrea Technologies. The 510(k) number is K083810.

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

PASS LP SPINAL SYSTEM received FDA 510(k) clearance on 2009-07-31, under 510(k) number K083810.

Who is the listed applicant for PASS LP SPINAL SYSTEM?

The FDA 510(k) record lists Medicrea Technologies 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 MNI.

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Other records listing Medicrea Technologies 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.

K102406PASS ANTERIOR SPINAL SYSTEMK100544IMPIX LUMBAR INTERBODY DEVICEK083798IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBFK100297PASS LP SPINAL SYSTEMK083308PASS LP SPINAL SYSTEMK082069PASS 2 SPINAL SYSTEM

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Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.

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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