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FDA 510(k)

HIPLOC COMPRESSION HIP SCREW

K-Number: K080685 · 2008-08-15

ApplicantBiomet Manufacturing, Inc.
Decision Date2008-08-15
Product CodeJDO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HIPLOC COMPRESSION HIP SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2008-08-15 under 510(k) number K080685. 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 HIPLOC COMPRESSION HIP SCREW?

HIPLOC COMPRESSION HIP SCREW is a medical device that received FDA 510(k) clearance on 2008-08-15. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K080685.

When did HIPLOC COMPRESSION HIP SCREW receive FDA 510(k) clearance?

HIPLOC COMPRESSION HIP SCREW received FDA 510(k) clearance on 2008-08-15, under 510(k) number K080685.

Who is the listed applicant for HIPLOC COMPRESSION HIP SCREW?

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

What is the FDA product code for HIPLOC COMPRESSION HIP SCREW?

The FDA product code for HIPLOC COMPRESSION HIP SCREW is JDO.

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Other records listing Biomet Manufacturing, Inc. as applicant

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K130390COMPREHENSIVE CONVERTIBLE GLENOIDK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSK113121COMPREHENSIVE REVERSE SHOULDERK080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSK071271BIOMET CABLE SYSTEMK070399100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES

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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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