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FDA 510(k)

CxHA PEEK Cervical IBF System

K-Number: K181115 · 2018-07-16

ApplicantInnovasis, Inc.
Decision Date2018-07-16
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CxHA PEEK Cervical IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2018-07-16 under 510(k) number K181115. 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 CxHA PEEK Cervical IBF System?

CxHA PEEK Cervical IBF System is a medical device that received FDA 510(k) clearance on 2018-07-16. The listed applicant is Innovasis, Inc.. The 510(k) number is K181115.

When did CxHA PEEK Cervical IBF System receive FDA 510(k) clearance?

CxHA PEEK Cervical IBF System received FDA 510(k) clearance on 2018-07-16, under 510(k) number K181115.

Who is the listed applicant for CxHA PEEK Cervical IBF System?

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

What is the FDA product code for CxHA PEEK Cervical IBF System?

The FDA product code for CxHA PEEK Cervical IBF System is ODP.

Other records listing Innovasis, Inc. 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.

K250076Endeavor™ Stand-Alone Cervical IBF SystemK251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K250603AxTiHA® Stand-Alone ALIF SystemK250182Innovasis Navigation InstrumentsK241276Vector™ Pedicle Screw SystemK231899HAtetracell™-C Titanium Cervical IBF System

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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.

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.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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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