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FDA 510(k)

INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI

K-Number: K852020 · 1985-05-22

ApplicantWarsaw Orthopedic, Inc.
Decision Date1985-05-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI is the device name listed in this FDA 510(k) record. The listed applicant is Warsaw Orthopedic, Inc.. It received FDA 510(k) clearance on 1985-05-22 under 510(k) number K852020. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI?

INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI is a medical device that received FDA 510(k) clearance on 1985-05-22. The listed applicant is Warsaw Orthopedic, Inc.. The 510(k) number is K852020.

When did INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI receive FDA 510(k) clearance?

INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI received FDA 510(k) clearance on 1985-05-22, under 510(k) number K852020.

Who is the listed applicant for INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI?

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

What is the FDA product code for INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI?

The FDA product code for INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI is HSB.

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Other records listing Warsaw Orthopedic, Inc. 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.

K892877CRADLE, HOSPITAL BED CLOTHINGK883783TSRH SACRAL SPINAL SCREWK883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATEK880211TSRH H/M HOOK HOLDERK880212TSRH H/M HOOK HOLDER W/ROD MOVERK880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD

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Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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