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FDA 510(k)

TAC-TITE (TM)

K-Number: K090128 · 2009-03-19

ApplicantCore Essence Orthopaedics, Inc.
Decision Date2009-03-19
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TAC-TITE (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Core Essence Orthopaedics, Inc.. It received FDA 510(k) clearance on 2009-03-19 under 510(k) number K090128. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAC-TITE (TM)?

TAC-TITE (TM) is a medical device that received FDA 510(k) clearance on 2009-03-19. The listed applicant is Core Essence Orthopaedics, Inc.. The 510(k) number is K090128.

When did TAC-TITE (TM) receive FDA 510(k) clearance?

TAC-TITE (TM) received FDA 510(k) clearance on 2009-03-19, under 510(k) number K090128.

Who is the listed applicant for TAC-TITE (TM)?

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

What is the FDA product code for TAC-TITE (TM)?

The FDA product code for TAC-TITE (TM) is GAT.

Other records listing Core Essence Orthopaedics, 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.

K101126PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS

Related Devices (Code: GAT)

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.

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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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