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FDA 510(k)

COHEN DISTRACTOR

K-Number: K972154 · 1997-08-11

ApplicantHowmedica Leibinger, Inc.
Decision Date1997-08-11
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COHEN DISTRACTOR 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 1997-08-11 under 510(k) number K972154. 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 COHEN DISTRACTOR?

COHEN DISTRACTOR is a medical device that received FDA 510(k) clearance on 1997-08-11. The listed applicant is Howmedica Leibinger, Inc.. The 510(k) number is K972154.

When did COHEN DISTRACTOR receive FDA 510(k) clearance?

COHEN DISTRACTOR received FDA 510(k) clearance on 1997-08-11, under 510(k) number K972154.

Who is the listed applicant for COHEN DISTRACTOR?

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 COHEN DISTRACTOR?

The FDA product code for COHEN DISTRACTOR 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 SCREWK972166GUERRERO - BELL DISTRACTORK961719EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESESK963030LEIBINGER IMF SCREWK970911LEE PLATEK963741LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS

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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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