Cleared Traditional

K884998 - SELBY INSTRUMENTATION

K884998 is an FDA 510(k) clearance for SELBY INSTRUMENTATION, manufactured by Advanced Spine Fixation Systems, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K884998 · Advanced Spine Fixation Systems, Inc. · Orthopedic device
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Jun 1989
Decision
202d
Days
Class 2
Risk

K884998 is an FDA 510(k) clearance for the SELBY INSTRUMENTATION. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Advanced Spine Fixation Systems, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on June 22, 1989 after a review of 202 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Advanced Spine Fixation Systems, Inc. devices

FDA 510(k) Submission Details - K884998

510(k) Number K884998 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 02, 1988
Decision Date June 22, 1989
Days to Decision 202 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 122d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 354
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K884998.
ACROMED BEADED SUBLAMINAR WIRE
K895439 · Acromed Corp. · Nov 1989
ACROMED BUTTON SPINAL WIRE
K895441 · Acromed Corp. · Nov 1989
CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL
K894472 · Buckman Co., Inc. · Oct 1989
KIRSCHNER SPINAL FIXATOR KMS-1
K884690 · Kirschner Medical Corp. · Jun 1989
ACROMED ILIAC SCREW
K884161 · Buckman Co., Inc. · May 1989
ACROMED SPINAL ROD AND SPINAL HOOKS
K884163 · Buckman Co., Inc. · Apr 1989