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FDA 510(k)

IMPIX MANTA CERVICAL INTERBODY DEVICE

K-Number: K100484 · 2010-03-16

ApplicantMedicrea
Decision Date2010-03-16
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPIX MANTA CERVICAL INTERBODY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea. It received FDA 510(k) clearance on 2010-03-16 under 510(k) number K100484. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPIX MANTA CERVICAL INTERBODY DEVICE?

IMPIX MANTA CERVICAL INTERBODY DEVICE is a medical device that received FDA 510(k) clearance on 2010-03-16. The listed applicant is Medicrea. The 510(k) number is K100484.

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

IMPIX MANTA CERVICAL INTERBODY DEVICE received FDA 510(k) clearance on 2010-03-16, under 510(k) number K100484.

Who is the listed applicant for IMPIX MANTA CERVICAL INTERBODY DEVICE?

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

What is the FDA product code for IMPIX MANTA CERVICAL INTERBODY DEVICE?

The FDA product code for IMPIX MANTA CERVICAL INTERBODY DEVICE is ODP.

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Other records listing Medicrea 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.

K062136PASS 2 SPINAL SYSTEMK050490OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLERK032094PASSMED SPINAL SYSTEM

Related Devices (Code: ODP)

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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