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FDA 510(k)

S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER

K-Number: K904746 · 1990-11-20

ApplicantJoint Medical Products Corp.
Decision Date1990-11-20
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER 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 1990-11-20 under 510(k) number K904746. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER?

S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Joint Medical Products Corp.. The 510(k) number is K904746.

When did S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER receive FDA 510(k) clearance?

S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER received FDA 510(k) clearance on 1990-11-20, under 510(k) number K904746.

Who is the listed applicant for S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER?

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(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER?

The FDA product code for S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER is JDK.

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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: JDK)

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.

K210062Mectaplug PE IIMedacta International S.A.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

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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