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FDA 510(k)

PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING

K-Number: K131674 · 2013-08-08

ApplicantBiomet Microfixation
Decision Date2013-08-08
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2013-08-08 under 510(k) number K131674. 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 PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING?

PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING is a medical device that received FDA 510(k) clearance on 2013-08-08. The listed applicant is Biomet Microfixation. The 510(k) number is K131674.

When did PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING receive FDA 510(k) clearance?

PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING received FDA 510(k) clearance on 2013-08-08, under 510(k) number K131674.

Who is the listed applicant for PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING?

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

What is the FDA product code for PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING?

The FDA product code for PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING is JEY.

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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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