Cleared Traditional

K874882 - ACROMED CROSS ROD CONNECTOR

K874882 is an FDA 510(k) clearance for ACROMED CROSS ROD CONNECTOR, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K874882 · Acromed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
79d
Days
Class 2
Risk

K874882 is an FDA 510(k) clearance for the ACROMED CROSS ROD CONNECTOR. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Acromed Corp. (Martinez, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 79 days - a notably fast clearance 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: 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 Acromed Corp. devices

FDA 510(k) Submission Details - K874882

510(k) Number K874882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1987
Decision Date February 18, 1988
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K874882.
LUMBAR IMPACTION SET
K875290 · T. Korossurgical Instruments Corp. · Mar 1988
TSRH H/M HOOK HOLDER
K880211 · Warsaw Orthopedic, Inc. · Mar 1988
TSRH H/M HOOK HOLDER W/ROD MOVER
K880212 · Warsaw Orthopedic, Inc. · Mar 1988
TSRH H/M TORQUE LIMITING WRENCH
K880214 · Warsaw Orthopedic, Inc. · Feb 1988
TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD
K880215 · Warsaw Orthopedic, Inc. · Feb 1988
WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM
K870830 · Warsaw Orthopedic, Inc. · May 1987