FDA 510(k)

SPHERISTEM TOTAL HIP PROSTHESIS

K-Number: K780497 · 1978-06-14

Decision Date1978-06-14

Product CodeJDG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SPHERISTEM TOTAL HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is American Ortomed Corp.. It received FDA 510(k) clearance on 1978-06-14 under 510(k) number K780497. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPHERISTEM TOTAL HIP PROSTHESIS?

SPHERISTEM TOTAL HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 1978-06-14. The listed applicant is American Ortomed Corp.. The 510(k) number is K780497.

When did SPHERISTEM TOTAL HIP PROSTHESIS receive FDA 510(k) clearance?

SPHERISTEM TOTAL HIP PROSTHESIS received FDA 510(k) clearance on 1978-06-14, under 510(k) number K780497.

Who is the listed applicant for SPHERISTEM TOTAL HIP PROSTHESIS?

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

What is the FDA product code for SPHERISTEM TOTAL HIP PROSTHESIS?

The FDA product code for SPHERISTEM TOTAL HIP PROSTHESIS is JDG.

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Other records listing American Ortomed Corp. as applicant

K842518UNILOC-CEMENTLESS & SELF TAP ACETABULAR K842466TITANIUM MITTELMEIER TYPE ACETABULAR K842465UNILOC K840413CEMENT RESTRICTOR K820719THE ICR KNEE

Related Devices (Code: JDG)

K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc.K193546Distal CentralizersBiomet, Inc.K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics K001984PROGENY FORGED COCR CEMENTED FEMORAL COMPONENTStelkast Company K992234THE TAPER-FIT TOTAL HIP SYSTEMCorin USA K962002AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMExactech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.