MICROFENESTRATED HIP REPLACEMENT COMPON.— 510(k) K770161

Name: FDA 510(k) clearance K770161
Creator: U.S. Food and Drug Administration
Published: 1977-01-26

Substantially Equivalent

Medishield, Inc.

FDA 510(k) clearance K770161 for MICROFENESTRATED HIP REPLACEMENT COMPON., Substantially Equivalent on 1977-01-26. Applicant: Medishield, Inc.. Device class: 2.

Clearance details

Applicant: Medishield, Inc.
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1977-01-24
Decision date: 1977-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT2000-09-27
K992234 — THE TAPER-FIT TOTAL HIP SYSTEM1999-11-10

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K781103 — SPECTRASCAN1978-09-27
K780645 — HMD-2000 BATTERY-POWERED MINI-DRILL, THE1978-05-03
K780646 — AIR-PWOERED COLDRILL1978-04-28
K780202 — MONOMER EVACUATION SYSTEM1978-02-21
K761020 — ANKLE (FREEMAN-SWANSON)1976-11-23

Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.