Cleared Traditional

K952783 - OXBORO-MEDICAL PIN COVERS

K952783 is an FDA 510(k) clearance for OXBORO-MEDICAL PIN COVERS, manufactured by Oxboro Medical Intl., Inc.. The device is a Class 2 Orthopedic device with product code LRN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K952783 · Oxboro Medical Intl., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
88d
Days
Class 2
Risk

K952783 is an FDA 510(k) clearance for the OXBORO-MEDICAL PIN COVERS. Classified as Wire, Surgical (product code LRN), Class II - Special Controls.

Submitted by Oxboro Medical Intl., Inc. (Ham Lake, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 88 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 Oxboro Medical Intl., Inc. devices

FDA 510(k) Submission Details - K952783

510(k) Number K952783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1995
Decision Date September 15, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRN Device Classification - Class 2, Special Controls

Product Code LRN Wire, Surgical
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 - LRN Wire, Surgical

Devices cleared under the same product code (LRN) and FDA review panel - the closest regulatory comparables to K952783.
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
K002755 · T. Korossurgical Instruments Corp. · Dec 2000
STAINLESS STEEL SOFT SUTURE WIRE
K990355 · Bregma International Trading Company , Ltd. · Jul 1999
J-FX CERCLAGE SYSTEM
K971682 · Johnson & Johnson Professionals, Inc. · Jun 1997
ORTHOPAEDIC WIRES
K942603 · Acu Med, Inc. · Nov 1994
TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)
K900926 · Howmedica Corp. · Apr 1990
SONGER WIRING SYSTEM
K892651 · Danek Medical, Inc. · Jul 1989