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FDA 510(k)

LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE

K-Number: K000594 · 2000-12-08

ApplicantStryker Leibinger
Decision Date2000-12-08
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger. It received FDA 510(k) clearance on 2000-12-08 under 510(k) number K000594. 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 LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE?

LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE is a medical device that received FDA 510(k) clearance on 2000-12-08. The listed applicant is Stryker Leibinger. The 510(k) number is K000594.

When did LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE receive FDA 510(k) clearance?

LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE received FDA 510(k) clearance on 2000-12-08, under 510(k) number K000594.

Who is the listed applicant for LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE?

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

What is the FDA product code for LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE?

The FDA product code for LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE is JEY.

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Other records listing Stryker Leibinger 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.

K052871STRYKER CUSTOM TI IMPLANTK043250STRYKER PATIENT SPECIFIC POLYMER IMPLANTK041651STRYKER LEIBINGER SKELETAL ANCHORING SYSTEMK040022STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEMK022579STRYKER NAVIGATION SYSTEM-KNEE MODULEK023449NON-INVASIVE PATIENT FIXATION SYSTEM

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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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