SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO— 510(k) K897141

Name: FDA 510(k) clearance K897141
Creator: U.S. Food and Drug Administration
Published: 1990-06-21

Substantially Equivalent for Some Indications

Stuart

FDA 510(k) clearance K897141 for SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO, Substantially Equivalent for Some Indications on 1990-06-21. Applicant: Stuart. Device class: 2.

Clearance details

Applicant: Stuart
Product code: Code JDN
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 1989-12-27
Decision date: 1990-06-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Greensburg, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDN

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K954856 — CANNULATED FEMORAL NAIL1996-03-08
K894184 — BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM1990-04-25
K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY1987-12-07
K873977 — NEW C-D SYSTEM FOR SPINAL SURGERY1987-12-07
K760649 — TOTAL SPINAL CORRECTION1976-10-05

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K890601 — STUART TITANIUM SURGICAL MESH1989-03-16
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K843445 — SACRAL BAR1985-02-13
K820034 — ANTERIOR DISTRACTION SYSTEM1982-03-11

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