Cleared Traditional

K070341 - LDR SPINE EASYSPINE POSTERIOR OSTEOSYNT...

K070341 is an FDA 510(k) clearance for LDR SPINE EASYSPINE POSTERIOR OSTEOSYNT..., manufactured by Ldr Spine USA. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K070341 · Ldr Spine USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
183d
Days
Class 2
Risk

K070341 is an FDA 510(k) clearance for the LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Ldr Spine USA (Austin, US). The FDA issued a Cleared decision on August 8, 2007 after a review of 183 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 Ldr Spine USA devices

FDA 510(k) Submission Details - K070341

510(k) Number K070341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2007
Decision Date August 08, 2007
Days to Decision 183 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
61d slower than avg
Panel avg: 122d · This submission: 183d
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 K070341.
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062447 · Medtronic Sofamor Danek, Inc. · Oct 2007
MODIFICATION TO OASYS SYSTEM
K072568 · Stryker Spine · Oct 2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K070742 · Medtronic Sofamor Danek · Sep 2007
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K070638 · Theken Spine, LLC · May 2007
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
K070300 · Depuy Spine, Inc. · Apr 2007
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591 · Medtronic Sofamor Danek, Inc. · Sep 2006