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FDA 510(k)

CUSTOM-HIP TOOL

K-Number: K051181 · 2005-05-23

ApplicantOrthopedic Sciences, Inc.
Decision Date2005-05-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CUSTOM-HIP TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Sciences, Inc.. It received FDA 510(k) clearance on 2005-05-23 under 510(k) number K051181. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM-HIP TOOL?

CUSTOM-HIP TOOL is a medical device that received FDA 510(k) clearance on 2005-05-23. The listed applicant is Orthopedic Sciences, Inc.. The 510(k) number is K051181.

When did CUSTOM-HIP TOOL receive FDA 510(k) clearance?

CUSTOM-HIP TOOL received FDA 510(k) clearance on 2005-05-23, under 510(k) number K051181.

Who is the listed applicant for CUSTOM-HIP TOOL?

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

What is the FDA product code for CUSTOM-HIP TOOL?

The FDA product code for CUSTOM-HIP TOOL is HRS.

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Other records listing Orthopedic Sciences, 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.

K091398ARTHROSCOPEK072175TITANIUM HIP TOOL LOCKING PLATEK063709TS-BONE HIP TOOLK063033MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANTK052538S-BONE HIP TOOLK051032TITANIUM-HIP TOOL

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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