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FDA 510(k)

OMEGA+ COMPRESSION SCREW SYSTEM

K-Number: K955306 · 1996-04-10

ApplicantHowmedica Corp.
Decision Date1996-04-10
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMEGA+ COMPRESSION 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 1996-04-10 under 510(k) number K955306. 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 OMEGA+ COMPRESSION SCREW SYSTEM?

OMEGA+ COMPRESSION SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1996-04-10. The listed applicant is Howmedica Corp.. The 510(k) number is K955306.

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

OMEGA+ COMPRESSION SCREW SYSTEM received FDA 510(k) clearance on 1996-04-10, under 510(k) number K955306.

Who is the listed applicant for OMEGA+ COMPRESSION 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 OMEGA+ COMPRESSION SCREW SYSTEM?

The FDA product code for OMEGA+ COMPRESSION 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)

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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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