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FDA 510(k)

ORTRON 90* HIP PROSTHESIS

K-Number: K802627 · 1980-12-16

ApplicantCintor Orthopaedic Div.
Decision Date1980-12-16
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTRON 90* HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Cintor Orthopaedic Div.. It received FDA 510(k) clearance on 1980-12-16 under 510(k) number K802627. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTRON 90* HIP PROSTHESIS?

ORTRON 90* HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 1980-12-16. The listed applicant is Cintor Orthopaedic Div.. The 510(k) number is K802627.

When did ORTRON 90* HIP PROSTHESIS receive FDA 510(k) clearance?

ORTRON 90* HIP PROSTHESIS received FDA 510(k) clearance on 1980-12-16, under 510(k) number K802627.

Who is the listed applicant for ORTRON 90* HIP PROSTHESIS?

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

What is the FDA product code for ORTRON 90* HIP PROSTHESIS?

The FDA product code for ORTRON 90* HIP PROSTHESIS is JDI.

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Other records listing Cintor Orthopaedic Div. 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.

K811451RADIAL HEAD PROSTHESISK810540KNEE PROSTHESISK810353HARRIS CEMENT RESTRICTORK803106AGINSKY NAILK803074FERNORAL HIP PROSTHESISK802814ORTHOFIX AXIALEXTERNAL FIXATION SYS.

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Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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