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FDA 510(k)

ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT

K-Number: K980999 · 1998-11-06

ApplicantInstrument Makar, Inc.
Decision Date1998-11-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Instrument Makar, Inc.. It received FDA 510(k) clearance on 1998-11-06 under 510(k) number K980999. 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 ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT?

ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K980999.

When did ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT receive FDA 510(k) clearance?

ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT received FDA 510(k) clearance on 1998-11-06, under 510(k) number K980999.

Who is the listed applicant for ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT?

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

What is the FDA product code for ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT?

The FDA product code for ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT is JWH.

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Other records listing Instrument Makar, Inc. 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.

K002600LITWIN CRUICATE ANCHORK963396BIOSPHERE SUTURE ANCHORK964364DISPOSABLE APRONK955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHK960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHORK943249BIOABSORBABLE INTERFERENCE SCREW

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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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