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FDA 510(k)

THE BIOPLATE FIXATION SYSTEM

K-Number: K961976 · 1996-08-16

ApplicantBiomedics
Decision Date1996-08-16
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE BIOPLATE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomedics. It received FDA 510(k) clearance on 1996-08-16 under 510(k) number K961976. 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 THE BIOPLATE FIXATION SYSTEM?

THE BIOPLATE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-16. The listed applicant is Biomedics. The 510(k) number is K961976.

When did THE BIOPLATE FIXATION SYSTEM receive FDA 510(k) clearance?

THE BIOPLATE FIXATION SYSTEM received FDA 510(k) clearance on 1996-08-16, under 510(k) number K961976.

Who is the listed applicant for THE BIOPLATE FIXATION SYSTEM?

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

What is the FDA product code for THE BIOPLATE FIXATION SYSTEM?

The FDA product code for THE BIOPLATE FIXATION SYSTEM is JEY.

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Other records listing Biomedics 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.

K992330THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYK984583THE BIOPLATE SHUNT CONNECTORK980983THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYK972463THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERYK953273BIOPLATE RIGID FIXATION BONE PLATING SYSTEMK943071THE TITANIUM 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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