Cleared Traditional

K930710 - SENTRY POSTERIOR SPINAL SYSTEM

K930710 is an FDA 510(k) clearance for SENTRY POSTERIOR SPINAL SYSTEM, manufactured by Sofamor Danek Mfg., Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K930710 · Sofamor Danek Mfg., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
232d
Days
Class 2
Risk

K930710 is an FDA 510(k) clearance for the SENTRY POSTERIOR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 232 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 Sofamor Danek Mfg., Inc. devices

FDA 510(k) Submission Details - K930710

510(k) Number K930710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1993
Decision Date October 01, 1993
Days to Decision 232 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 122d · This submission: 232d
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 310
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K930710.
TI-FRAME
K934860 · Johnson & Johnson Professionals, Inc. · Jun 1994
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205 · Danek Medical, Inc. · May 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891 · Synthes (Usa) · Apr 1994
COTREL - DUBOUSSET SPINE IMPLANTS
K921056 · Buckman Co., Inc. · Jun 1993
COMPACT COTREL -- DUBOUSSET SPINE SYSTEM
K921767 · Buckman Co., Inc. · Jun 1993
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
K921948 · Synthes (Usa) · Jun 1993