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FDA 510(k)

OSTEOSORB TACK FIXATION SYSTEM

K-Number: K030989 · 2004-04-01

ApplicantNoviace Corporation
Decision Date2004-04-01
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOSORB TACK FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Noviace Corporation. It received FDA 510(k) clearance on 2004-04-01 under 510(k) number K030989. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOSORB TACK FIXATION SYSTEM?

OSTEOSORB TACK FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-01. The listed applicant is Noviace Corporation. The 510(k) number is K030989.

When did OSTEOSORB TACK FIXATION SYSTEM receive FDA 510(k) clearance?

OSTEOSORB TACK FIXATION SYSTEM received FDA 510(k) clearance on 2004-04-01, under 510(k) number K030989.

Who is the listed applicant for OSTEOSORB TACK FIXATION SYSTEM?

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

What is the FDA product code for OSTEOSORB TACK FIXATION SYSTEM?

The FDA product code for OSTEOSORB TACK FIXATION SYSTEM is JEY.

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Other records listing Noviace Corporation as applicant

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Related Devices (Code: JEY)

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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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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