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FDA 510(k)

PEDIATRIC OSTEOTOMY SYSTEM

K-Number: K945233 · 1995-02-01

ApplicantHowmedica Corp.
Decision Date1995-02-01
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC OSTEOTOMY 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 1995-02-01 under 510(k) number K945233. 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 PEDIATRIC OSTEOTOMY SYSTEM?

PEDIATRIC OSTEOTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-01. The listed applicant is Howmedica Corp.. The 510(k) number is K945233.

When did PEDIATRIC OSTEOTOMY SYSTEM receive FDA 510(k) clearance?

PEDIATRIC OSTEOTOMY SYSTEM received FDA 510(k) clearance on 1995-02-01, under 510(k) number K945233.

Who is the listed applicant for PEDIATRIC OSTEOTOMY 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 PEDIATRIC OSTEOTOMY SYSTEM?

The FDA product code for PEDIATRIC OSTEOTOMY 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 GlobalK253202Hoffmann LRF SystemStryker GmbHK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.

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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