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FDA 510(k)

VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE

K-Number: K964649 · 1997-01-24

ApplicantHowmedica Leibinger, Inc.
Decision Date1997-01-24
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Leibinger, Inc.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K964649. 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 VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE?

VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Howmedica Leibinger, Inc.. The 510(k) number is K964649.

When did VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE receive FDA 510(k) clearance?

VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964649.

Who is the listed applicant for VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE?

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

What is the FDA product code for VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE?

The FDA product code for VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE is JEY.

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Other records listing Howmedica Leibinger, 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.

K970912LEIBINGER SELF-DRILLING SCREWK972154COHEN DISTRACTORK972166GUERRERO - BELL DISTRACTORK961719EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESESK970911LEE PLATEK963030LEIBINGER IMF SCREW

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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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