MNH · Class II · 21 CFR 888.3070

FDA Product Code MNH: Orthosis, Spondylolisthesis Spinal Fixation

Leading manufacturers include Acromed Corp., Medtronic Sofamor Danek, Inc. and Depuyacromed.

309
Total
309
Cleared
127d
Avg days
1995
Since
309 devices
241–264 of 309
Cleared Aug 11, 1995
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K950074
Wrightmedicaltechnologyinc
Orthopedic · 214d
Cleared Aug 11, 1995
ACROMED PEDICLE SCREW
K951116
Acromed Corp.
Orthopedic · 154d
Cleared Aug 07, 1995
TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)
K946348
Sofamor Danek USA,Inc.
Orthopedic · 220d
Cleared Jul 26, 1995
5.8MM DIAMETER ANCHOR SCREW
K951308
Advanced Spine Fixation Systems, Inc.
Orthopedic · 126d
Cleared Jul 25, 1995
TITANIUM LOW PROFILE CROSS BAR
K951172
Advanced Spine Fixation Systems, Inc.
Orthopedic · 132d
Cleared Jun 22, 1995
ISOLA SPINE SYSTEM
K944737
Acromed Corp.
Orthopedic · 269d
Cleared Jun 20, 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353
Smith & Nephew, Inc.
Orthopedic · 880d
Cleared Jun 14, 1995
ROGOZINSKI SPINAL ROD SYSTEM SCREW
K930298
Smith & Nephew Richards, Inc.
Orthopedic · 874d
Cleared May 30, 1995
ISOLA OPEN AND CLOSED SCREWS
K944756
Acromed Corp.
Orthopedic · 246d
Cleared May 05, 1995
VSP (VARIABLE SCREW PLACEMENT)
K944736
Acromed Corp.
Orthopedic · 221d
Cleared Apr 26, 1995
SELBY INSTRUMENTATION
K943775
Advanced Spine Fixation Systems, Inc.
Orthopedic · 267d
Cleared Apr 26, 1995
SELBY INSTRUMENTATION
K945064
Advanced Spine Fixation Systems, Inc.
Orthopedic · 194d
Cleared Feb 14, 1995
SELBY INSTRUMENTATION
K942387
Advanced Spine Fixation Systems, Inc.
Orthopedic · 271d
Cleared Jan 20, 1995
TSRH SPINAL SCREWS
K932029
Sofamor Danek Mfg., Inc.
Orthopedic · 633d