FDA 510(k)

S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP

K-Number: K851421 · 1985-06-04

Decision Date1985-06-04

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP 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 1985-06-04 under 510(k) number K851421. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP?

S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP is a medical device that received FDA 510(k) clearance on 1985-06-04. The listed applicant is Joint Medical Products Corp.. The 510(k) number is K851421.

When did S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP receive FDA 510(k) clearance?

S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP received FDA 510(k) clearance on 1985-06-04, under 510(k) number K851421.

Who is the listed applicant for S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP?

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 ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP?

The FDA product code for S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP is LPH.

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Other records listing Joint Medical Products Corp. as applicant

K955511ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP K954935S-ROM FEMORAL HIP STEM - SIZE 14 X 8 K944321S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II K951726S-ROM ZTP UHMWPE ACETABULAR CUP K951084S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS K951000ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM

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Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, 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.