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FDA 510(k)

PIPELINE KNEE SYSTEM

K-Number: K123692 · 2013-05-24

ApplicantPipeline Orthopedics
Decision Date2013-05-24
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIPELINE KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pipeline Orthopedics. It received FDA 510(k) clearance on 2013-05-24 under 510(k) number K123692. 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 PIPELINE KNEE SYSTEM?

PIPELINE KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-05-24. The listed applicant is Pipeline Orthopedics. The 510(k) number is K123692.

When did PIPELINE KNEE SYSTEM receive FDA 510(k) clearance?

PIPELINE KNEE SYSTEM received FDA 510(k) clearance on 2013-05-24, under 510(k) number K123692.

Who is the listed applicant for PIPELINE KNEE SYSTEM?

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

What is the FDA product code for PIPELINE KNEE SYSTEM?

The FDA product code for PIPELINE KNEE SYSTEM is JWH.

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Other records listing Pipeline 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.

K131368NEO KNEE SYSTEMK132046PIPELINE KNEE SYSTEMK130353PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)K131237PIPELINE TOTAL HIP SYSTEMK122500NEO PS KNEE SYSTEMK120313NEO CR KNEE SYSTEM

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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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