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FDA 510(k)

PLUS FRACTURE HEAD PROSTHESIS

K-Number: K990309 · 1999-03-15

ApplicantPlus Orthopedics
Decision Date1999-03-15
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLUS FRACTURE HEAD PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 1999-03-15 under 510(k) number K990309. 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 PLUS FRACTURE HEAD PROSTHESIS?

PLUS FRACTURE HEAD PROSTHESIS is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Plus Orthopedics. The 510(k) number is K990309.

When did PLUS FRACTURE HEAD PROSTHESIS receive FDA 510(k) clearance?

PLUS FRACTURE HEAD PROSTHESIS received FDA 510(k) clearance on 1999-03-15, under 510(k) number K990309.

Who is the listed applicant for PLUS FRACTURE HEAD PROSTHESIS?

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

What is the FDA product code for PLUS FRACTURE HEAD PROSTHESIS?

The FDA product code for PLUS FRACTURE HEAD PROSTHESIS is KWL.

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Other records listing Plus Orthopedics 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.

K032126PROMOS SHOULDERK033763MODIFICATION TO SLIM GLIDING NAIL SYSTEMK032709MODULAR PLUS HIP STEMK032548IP-XS COMPRESSION NAIL SYSTEMK032215VKS/TC-PLUS REVISION KNEEK032052UC-PLUS SOLUTION UNICONDYLAR KNEE

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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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