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FDA 510(k)

9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS

K-Number: K953386 · 1995-09-15

ApplicantImplant Innovations, Inc.
Decision Date1995-09-15
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS 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 1995-09-15 under 510(k) number K953386. 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 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS?

9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K953386.

When did 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS receive FDA 510(k) clearance?

9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS received FDA 510(k) clearance on 1995-09-15, under 510(k) number K953386.

Who is the listed applicant for 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS?

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 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS?

The FDA product code for 9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS 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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