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FDA 510(k)

XTAC

K-Number: K061934 · 2007-07-17

ApplicantOsteogenics, Inc.
Decision Date2007-07-17
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XTAC is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics, Inc.. It received FDA 510(k) clearance on 2007-07-17 under 510(k) number K061934. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTAC?

XTAC is a medical device that received FDA 510(k) clearance on 2007-07-17. The listed applicant is Osteogenics, Inc.. The 510(k) number is K061934.

When did XTAC receive FDA 510(k) clearance?

XTAC received FDA 510(k) clearance on 2007-07-17, under 510(k) number K061934.

Who is the listed applicant for XTAC?

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

What is the FDA product code for XTAC?

The FDA product code for XTAC is FTL.

Other records listing Osteogenics, 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.

K983753STAR TEMPORARY WOUND COVERK964537BONESOURCE HYDROXYAPATITE CEMENT (HAC)K953339BONESOURCE HYDROXYAPATITE CEMENT (HAC)

Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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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