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FDA 510(k)

MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM

K-Number: K872223 · 1987-06-26

ApplicantHowmedica Corp.
Decision Date1987-06-26
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1987-06-26 under 510(k) number K872223. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM?

MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1987-06-26. The listed applicant is Howmedica Corp.. The 510(k) number is K872223.

When did MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM receive FDA 510(k) clearance?

MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM received FDA 510(k) clearance on 1987-06-26, under 510(k) number K872223.

Who is the listed applicant for MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM?

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

What is the FDA product code for MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM?

The FDA product code for MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM is KTT.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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