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FDA 510(k)

SYMMETRIC TOTAL KNEE AGUMENTS

K-Number: K100370 · 2011-03-07

ApplicantSignal Medical Corp.
Decision Date2011-03-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYMMETRIC TOTAL KNEE AGUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Signal Medical Corp.. It received FDA 510(k) clearance on 2011-03-07 under 510(k) number K100370. 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 SYMMETRIC TOTAL KNEE AGUMENTS?

SYMMETRIC TOTAL KNEE AGUMENTS is a medical device that received FDA 510(k) clearance on 2011-03-07. The listed applicant is Signal Medical Corp.. The 510(k) number is K100370.

When did SYMMETRIC TOTAL KNEE AGUMENTS receive FDA 510(k) clearance?

SYMMETRIC TOTAL KNEE AGUMENTS received FDA 510(k) clearance on 2011-03-07, under 510(k) number K100370.

Who is the listed applicant for SYMMETRIC TOTAL KNEE AGUMENTS?

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

What is the FDA product code for SYMMETRIC TOTAL KNEE AGUMENTS?

The FDA product code for SYMMETRIC TOTAL KNEE AGUMENTS is JWH.

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Other records listing Signal Medical Corp. 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.

K073674BONE FIXATION WIRE (KIRSCHNER WIRE)K051510SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEMK043289E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOTK022382RHS ACETABULAR COMPONENTK021063GREAT TOE IMPLANTK981302SMC 28MM CERAMIC FEMORAL HEADS

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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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