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FDA 510(k)

S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD

K-Number: K913231 · 1991-12-20

ApplicantJoint Medical Products Corp.
Decision Date1991-12-20
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD 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 1991-12-20 under 510(k) number K913231. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD?

S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD is a medical device that received FDA 510(k) clearance on 1991-12-20. The listed applicant is Joint Medical Products Corp.. The 510(k) number is K913231.

When did S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD receive FDA 510(k) clearance?

S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD received FDA 510(k) clearance on 1991-12-20, under 510(k) number K913231.

Who is the listed applicant for S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD?

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) TOTAL LHIP SYSTEM W/CERAMIC HEAD?

The FDA product code for S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD is JDI.

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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: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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