Cleared Traditional

K983881 - COBRA EXTERNAL FIXATOR

K983881 is an FDA 510(k) clearance for COBRA EXTERNAL FIXATOR, manufactured by Orthopaedic Innovations, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K983881 · Orthopaedic Innovations, Inc. · Orthopedic device
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Dec 1998
Decision
32d
Days
Class 2
Risk

K983881 is an FDA 510(k) clearance for the COBRA EXTERNAL FIXATOR. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Orthopaedic Innovations, Inc. (Golden Valley, US). The FDA issued a Cleared decision on December 4, 1998 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: 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 Orthopaedic Innovations, Inc. devices

FDA 510(k) Submission Details - K983881

510(k) Number K983881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1998
Decision Date December 04, 1998
Days to Decision 32 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1075
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K983881.
DEPUY ACE SPIDER PLATE
K984458 · Depuy Ace Medical Co. · Dec 1998
DEPUY ACE TIMAX META PLATE
K983853 · Depuy Ace Medical Co. · Dec 1998
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967 · Biomet, Inc. · Dec 1998
HOFFMANN II MIAMI POST
K983419 · Howmedica Corp. · Nov 1998
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
K982531 · Howmedica Corp. · Oct 1998
MINI-FIXATOR FOR COLLES FRACTURES
K982982 · Biomet, Inc. · Oct 1998