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FDA 510(k)

LUHR MANDIBULAR/SMALL FIXATION IMPLANTS

K-Number: K950595 · 1995-07-12

ApplicantHowmedica Corp.
Decision Date1995-07-12
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUHR MANDIBULAR/SMALL FIXATION IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1995-07-12 under 510(k) number K950595. 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 LUHR MANDIBULAR/SMALL FIXATION IMPLANTS?

LUHR MANDIBULAR/SMALL FIXATION IMPLANTS is a medical device that received FDA 510(k) clearance on 1995-07-12. The listed applicant is Howmedica Corp.. The 510(k) number is K950595.

When did LUHR MANDIBULAR/SMALL FIXATION IMPLANTS receive FDA 510(k) clearance?

LUHR MANDIBULAR/SMALL FIXATION IMPLANTS received FDA 510(k) clearance on 1995-07-12, under 510(k) number K950595.

Who is the listed applicant for LUHR MANDIBULAR/SMALL FIXATION IMPLANTS?

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

What is the FDA product code for LUHR MANDIBULAR/SMALL FIXATION IMPLANTS?

The FDA product code for LUHR MANDIBULAR/SMALL FIXATION IMPLANTS is JEY.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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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