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FDA 510(k)

S-ROM TOTAL HIP REPLACEMENT SYSTEM

K-Number: K935078 · 1994-03-09

ApplicantJoint Medical Products Corp.
Decision Date1994-03-09
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

S-ROM TOTAL HIP REPLACEMENT SYSTEM 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 1994-03-09 under 510(k) number K935078. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the S-ROM TOTAL HIP REPLACEMENT SYSTEM?

S-ROM TOTAL HIP REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-09. The listed applicant is Joint Medical Products Corp.. The 510(k) number is K935078.

When did S-ROM TOTAL HIP REPLACEMENT SYSTEM receive FDA 510(k) clearance?

S-ROM TOTAL HIP REPLACEMENT SYSTEM received FDA 510(k) clearance on 1994-03-09, under 510(k) number K935078.

Who is the listed applicant for S-ROM TOTAL HIP REPLACEMENT SYSTEM?

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 TOTAL HIP REPLACEMENT SYSTEM?

The FDA product code for S-ROM TOTAL HIP REPLACEMENT SYSTEM is JDG.

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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: JDG)

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.

K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc.K193546Distal CentralizersBiomet, Inc.K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker OrthopaedicsK001984PROGENY FORGED COCR CEMENTED FEMORAL COMPONENTStelkast CompanyK992234THE TAPER-FIT TOTAL HIP SYSTEMCorin USAK962002AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMExactech, Inc.

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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