Cleared Traditional

K872715 - UNIVERSAL INSTRUMENTATION(CD) FOR SPINA...

K872715 is an FDA 510(k) clearance for UNIVERSAL INSTRUMENTATION(CD) FOR SPINA..., manufactured by Roseburg SA. The device is a Class 2 Orthopedic device with product code JDN cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K872715 · Roseburg SA · Orthopedic device
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Dec 1987
Decision
150d
Days
Class 2
Risk

K872715 is an FDA 510(k) clearance for the UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY. Classified as Implant, Fixation Device, Spinal (product code JDN), Class II - Special Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on December 7, 1987 after a review of 150 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Roseburg SA devices

FDA 510(k) Submission Details - K872715

510(k) Number K872715 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 10, 1987
Decision Date December 07, 1987
Days to Decision 150 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 122d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDN Device Classification - Class 2, Special Controls

Product Code JDN Implant, Fixation Device, Spinal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.