UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY— 510(k) K872715

Name: FDA 510(k) clearance K872715
Creator: U.S. Food and Drug Administration
Published: 1987-12-07

Substantially Equivalent for Some Indications

Roseburg SA

FDA 510(k) clearance K872715 for UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY, Substantially Equivalent for Some Indications on 1987-12-07. Applicant: Roseburg SA. Device class: 2.

Clearance details

Applicant: Roseburg SA
Product code: Code JDN
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 1987-07-10
Decision date: 1987-12-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDN

view all

K954856 — CANNULATED FEMORAL NAIL1996-03-08
K897141 — SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO1990-06-21
K894184 — BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM1990-04-25
K873977 — NEW C-D SYSTEM FOR SPINAL SURGERY1987-12-07
K760649 — TOTAL SPINAL CORRECTION1976-10-05

More clearances from Roseburg SA

view all

K931155 — STAPLE, FIXATION BONE; SCREW FIXATION BONE1994-09-01
K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES1989-03-09
K885275 — ASSENAT-BLESCHET SUNGLASSES1989-01-24
K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES1988-08-26
K874317 — POIRIER KID-ROLLER MANUAL WHEELCHAIR1987-11-17

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