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FDA 510(k)

TC-PLUS POROUS FEMORAL COMPONENTS

K-Number: K011258 · 2001-05-24

ApplicantPlus Orthopedics
Decision Date2001-05-24
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TC-PLUS POROUS FEMORAL COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2001-05-24 under 510(k) number K011258. 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 TC-PLUS POROUS FEMORAL COMPONENTS?

TC-PLUS POROUS FEMORAL COMPONENTS is a medical device that received FDA 510(k) clearance on 2001-05-24. The listed applicant is Plus Orthopedics. The 510(k) number is K011258.

When did TC-PLUS POROUS FEMORAL COMPONENTS receive FDA 510(k) clearance?

TC-PLUS POROUS FEMORAL COMPONENTS received FDA 510(k) clearance on 2001-05-24, under 510(k) number K011258.

Who is the listed applicant for TC-PLUS POROUS FEMORAL COMPONENTS?

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 TC-PLUS POROUS FEMORAL COMPONENTS?

The FDA product code for TC-PLUS POROUS FEMORAL COMPONENTS is JWH.

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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: 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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