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FDA 510(k)

S-ROM NOILES CRUCIATE RETAINING KNEE

K-Number: K936037 · 1994-10-03

ApplicantJoint Medical Products Corp.
Decision Date1994-10-03
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

S-ROM NOILES CRUCIATE RETAINING KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Joint Medical Products Corp.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K936037. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the S-ROM NOILES CRUCIATE RETAINING KNEE?

S-ROM NOILES CRUCIATE RETAINING KNEE is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Joint Medical Products Corp.. The 510(k) number is K936037.

When did S-ROM NOILES CRUCIATE RETAINING KNEE receive FDA 510(k) clearance?

S-ROM NOILES CRUCIATE RETAINING KNEE received FDA 510(k) clearance on 1994-10-03, under 510(k) number K936037.

Who is the listed applicant for S-ROM NOILES CRUCIATE RETAINING KNEE?

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

What is the FDA product code for S-ROM NOILES CRUCIATE RETAINING KNEE?

The FDA product code for S-ROM NOILES CRUCIATE RETAINING KNEE is JWH.

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Other records listing Joint Medical Products 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.

K955511ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUPK954935S-ROM FEMORAL HIP STEM - SIZE 14 X 8K944321S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM IIK951726S-ROM ZTP UHMWPE ACETABULAR CUPK951084S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESISK951000ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP 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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