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FDA 510(k)

SureMAX Family of Cervical Spacers

K-Number: K193359 · 2020-01-03

ApplicantAdditive Implants, Inc.
Decision Date2020-01-03
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SureMAX Family of Cervical Spacers is the device name listed in this FDA 510(k) record. The listed applicant is Additive Implants, Inc.. It received FDA 510(k) clearance on 2020-01-03 under 510(k) number K193359. 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 SureMAX Family of Cervical Spacers?

SureMAX Family of Cervical Spacers is a medical device that received FDA 510(k) clearance on 2020-01-03. The listed applicant is Additive Implants, Inc.. The 510(k) number is K193359.

When did SureMAX Family of Cervical Spacers receive FDA 510(k) clearance?

SureMAX Family of Cervical Spacers received FDA 510(k) clearance on 2020-01-03, under 510(k) number K193359.

Who is the listed applicant for SureMAX Family of Cervical Spacers?

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

What is the FDA product code for SureMAX Family of Cervical Spacers?

The FDA product code for SureMAX Family of Cervical Spacers is ODP.

Other records listing Additive Implants, 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.

K211111SureMAX-SA Cervical Standalone SystemK182477Cervical Spacer

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

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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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