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FDA 510(k)

Tryptik Ti

K-Number: K230583 · 2023-03-22

ApplicantSpineart SA
Decision Date2023-03-22
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tryptik Ti is the device name listed in this FDA 510(k) record. The listed applicant is Spineart SA. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K230583. 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 Tryptik Ti?

Tryptik Ti is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Spineart SA. The 510(k) number is K230583.

When did Tryptik Ti receive FDA 510(k) clearance?

Tryptik Ti received FDA 510(k) clearance on 2023-03-22, under 510(k) number K230583.

Who is the listed applicant for Tryptik Ti?

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

What is the FDA product code for Tryptik Ti?

The FDA product code for Tryptik Ti is ODP.

Other records listing Spineart SA as applicant

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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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