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FDA 510(k)

101 TOTAL CONDYLAR KNEE SYSTEM

K-Number: K813598 · 1982-02-10

ApplicantIntermedics Orthopedics
Decision Date1982-02-10
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

101 TOTAL CONDYLAR KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1982-02-10 under 510(k) number K813598. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 101 TOTAL CONDYLAR KNEE SYSTEM?

101 TOTAL CONDYLAR KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1982-02-10. The listed applicant is Intermedics Orthopedics. The 510(k) number is K813598.

When did 101 TOTAL CONDYLAR KNEE SYSTEM receive FDA 510(k) clearance?

101 TOTAL CONDYLAR KNEE SYSTEM received FDA 510(k) clearance on 1982-02-10, under 510(k) number K813598.

Who is the listed applicant for 101 TOTAL CONDYLAR KNEE SYSTEM?

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

What is the FDA product code for 101 TOTAL CONDYLAR KNEE SYSTEM?

The FDA product code for 101 TOTAL CONDYLAR KNEE SYSTEM is JWH.

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Other records listing Intermedics Orthopedics as applicant

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) 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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