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FDA 510(k)

TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE

K-Number: K031183 · 2003-07-14

ApplicantCenterpulse Orthopedics, Inc.
Decision Date2003-07-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE is the device name listed in this FDA 510(k) record. The listed applicant is Centerpulse Orthopedics, Inc.. It received FDA 510(k) clearance on 2003-07-14 under 510(k) number K031183. 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 TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE?

TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE is a medical device that received FDA 510(k) clearance on 2003-07-14. The listed applicant is Centerpulse Orthopedics, Inc.. The 510(k) number is K031183.

When did TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE receive FDA 510(k) clearance?

TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE received FDA 510(k) clearance on 2003-07-14, under 510(k) number K031183.

Who is the listed applicant for TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE?

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

What is the FDA product code for TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE?

The FDA product code for TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE is JWH.

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Other records listing Centerpulse Orthopedics, Inc. 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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