Cleared Traditional

K980512 - LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW

K980512 is an FDA 510(k) clearance for LORENZ RECONSTRUCTION SYSTEM WITH MODUL..., manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980512 · Walter Lorenz Surgical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
90d
Days
Class 2
Risk

K980512 is an FDA 510(k) clearance for the LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 11, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Walter Lorenz Surgical, Inc. devices

FDA 510(k) Submission Details - K980512

510(k) Number K980512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1998
Decision Date May 11, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K980512.
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K980983 · Biomedics · Jun 1998
LACTOSORB PANELS AND FASTENERS
K980927 · Biomet, Inc. · Jun 1998
20-HOLE ADAPTATION PLATE
K981070 · Biomet, Inc. · May 1998
FRIOS BONESHIELD
K973924 · Friatec AG · May 1998
SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)
K974555 · Synthes (Usa) · Mar 1998
SYNTHES RESORBABLE FIXATION SYSTEM
K974554 · Synthes (Usa) · Feb 1998