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FDA 510(k)

BIOMET CONCENTRIC HEX SCREW

K-Number: K781389 · 1978-08-21

ApplicantBiomet, Inc.
Decision Date1978-08-21
Product CodeJDO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET CONCENTRIC HEX SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1978-08-21 under 510(k) number K781389. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET CONCENTRIC HEX SCREW?

BIOMET CONCENTRIC HEX SCREW is a medical device that received FDA 510(k) clearance on 1978-08-21. The listed applicant is Biomet, Inc.. The 510(k) number is K781389.

When did BIOMET CONCENTRIC HEX SCREW receive FDA 510(k) clearance?

BIOMET CONCENTRIC HEX SCREW received FDA 510(k) clearance on 1978-08-21, under 510(k) number K781389.

Who is the listed applicant for BIOMET CONCENTRIC HEX SCREW?

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

What is the FDA product code for BIOMET CONCENTRIC HEX SCREW?

The FDA product code for BIOMET CONCENTRIC HEX SCREW is JDO.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: JDO)

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.

K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric TechnologiesK213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc.K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric TraumaK193029CONQUEST FNSmith & Nephew, Inc.K173826THP Hip Fracture Plating SystemBiomet, Inc.K172785CONQUEST FNSmith & Nephew

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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