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FDA 510(k)

3I OSSEOUS FIXATION SYSTEM(S)

K-Number: K960914 · 1996-04-04

ApplicantImplant Innovations, Inc.
Decision Date1996-04-04
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3I OSSEOUS FIXATION SYSTEM(S) is the device name listed in this FDA 510(k) record. The listed applicant is Implant Innovations, Inc.. It received FDA 510(k) clearance on 1996-04-04 under 510(k) number K960914. 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 3I OSSEOUS FIXATION SYSTEM(S)?

3I OSSEOUS FIXATION SYSTEM(S) is a medical device that received FDA 510(k) clearance on 1996-04-04. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K960914.

When did 3I OSSEOUS FIXATION SYSTEM(S) receive FDA 510(k) clearance?

3I OSSEOUS FIXATION SYSTEM(S) received FDA 510(k) clearance on 1996-04-04, under 510(k) number K960914.

Who is the listed applicant for 3I OSSEOUS FIXATION SYSTEM(S)?

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

What is the FDA product code for 3I OSSEOUS FIXATION SYSTEM(S)?

The FDA product code for 3I OSSEOUS FIXATION SYSTEM(S) is JEY.

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Other records listing Implant Innovations, 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.

K062636OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTSK0633413I OSSEOTITE CERTAIN DENTAL IMPLANTSK063286OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITEK063403CONICAL ANGLED ABUTMENTK061629CERTAIN PREVAIL DENTAL IMPLANTK062432NANOTITE DENTAL IMPLANTS

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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

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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