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FDA 510(k)

TF-II HIP PROSTHESIS

K-Number: K843995 · 1985-04-23

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1985-04-23
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TF-II HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. It received FDA 510(k) clearance on 1985-04-23 under 510(k) number K843995. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TF-II HIP PROSTHESIS?

TF-II HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 1985-04-23. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K843995.

When did TF-II HIP PROSTHESIS receive FDA 510(k) clearance?

TF-II HIP PROSTHESIS received FDA 510(k) clearance on 1985-04-23, under 510(k) number K843995.

Who is the listed applicant for TF-II HIP PROSTHESIS?

The FDA 510(k) record lists Dow Corning Corp. Healthcare Industries Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TF-II HIP PROSTHESIS?

The FDA product code for TF-II HIP PROSTHESIS is KWL.

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Other records listing Dow Corning Corp. Healthcare Industries Materials 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.

K853186SILASTIC INFLATABLE BONE PLUG H.P.K844637WHITESIDE ACRYLIC CEMENT SPACER SLEEVEK850255DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMETK842559WHITESIDE ORTHOLOC TOTAL HIP FEMORALK840357SSA HIP PROSTHESISK831479METAL-BACKED ACETABULAR CUP

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Related Devices (Code: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH

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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