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FDA 510(k)

IMPIX LUMBAR INTERBODY DEVICE

K-Number: K100544 · 2010-07-22

ApplicantMedicrea Technologies
Decision Date2010-07-22
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPIX LUMBAR INTERBODY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea Technologies. It received FDA 510(k) clearance on 2010-07-22 under 510(k) number K100544. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPIX LUMBAR INTERBODY DEVICE?

IMPIX LUMBAR INTERBODY DEVICE is a medical device that received FDA 510(k) clearance on 2010-07-22. The listed applicant is Medicrea Technologies. The 510(k) number is K100544.

When did IMPIX LUMBAR INTERBODY DEVICE receive FDA 510(k) clearance?

IMPIX LUMBAR INTERBODY DEVICE received FDA 510(k) clearance on 2010-07-22, under 510(k) number K100544.

Who is the listed applicant for IMPIX LUMBAR INTERBODY DEVICE?

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 IMPIX LUMBAR INTERBODY DEVICE?

The FDA product code for IMPIX LUMBAR INTERBODY DEVICE is MAX.

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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 SYSTEMK083798IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBFK100297PASS LP SPINAL SYSTEMK083810PASS LP SPINAL SYSTEMK083308PASS LP SPINAL SYSTEMK082069PASS 2 SPINAL SYSTEM

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Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development 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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