Cleared Traditional

K875291 - SPINAL SURGERY FRAME

K875291 is an FDA 510(k) clearance for SPINAL SURGERY FRAME, manufactured by T. Korossurgical Instruments Corp.. The device is a Class 1 General & Plastic Surgery device with product code BWN cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K875291 · T. Korossurgical Instruments Corp. · General & Plastic Surgery device
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Jan 1988
Decision
23d
Days
Class 1
Risk

K875291 is an FDA 510(k) clearance for the SPINAL SURGERY FRAME. Classified as Table And Attachments, Operating-room (product code BWN), Class I - General Controls.

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all T. Korossurgical Instruments Corp. devices

FDA 510(k) Submission Details - K875291

510(k) Number K875291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1987
Decision Date January 22, 1988
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

BWN Device Classification - Class 1, General Controls

Product Code BWN Table And Attachments, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.