KWP · Class II · 21 CFR 888.3050

FDA Product Code KWP: Appliance, Fixation, Spinal Interlaminal

Leading manufacturers include Medtronic Sofamor Danek, Medtronic Sofamor Danek, Inc. and Synthes (Usa).

430
Total
430
Cleared
130d
Avg days
1978
Since
430 devices
313–336 of 430
Cleared Feb 09, 1996
CD LIBERTY POSTERIOR SPINCAL SYSTEM
K951164
Sofamor Danek USA,Inc.
Orthopedic · 332d
Cleared Feb 09, 1996
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K955173
Osteotech, Inc.
Orthopedic · 88d
Cleared Jan 25, 1996
CENTRA-LINE GRAPPLE, VARIFIX SYSTEM
K954770
Advanced Spine Fixation Systems, Inc.
Orthopedic · 100d
Cleared Jan 16, 1996
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645
Sofamor Danek USA,Inc.
Orthopedic · 98d
Cleared Dec 19, 1995
SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
K936294
Sofamor Danek Mfg., Inc.
Orthopedic · 739d
Cleared Dec 19, 1995
CLAMP ASSEMBLY
K953599
J.B.S., S.A.
Orthopedic · 139d
Cleared Jul 11, 1995
J.B.S. CERVICAL SPINE SYSTEM
K942432
J.B.S., S.A.
Orthopedic · 417d
Cleared Jun 22, 1995
WEBB-MORLEY SPINE SYSTEM
K945781
Electro-Biology, Inc.
Orthopedic · 209d
Cleared May 31, 1995
BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
K945435
Arcan Orthopaedic Corp.
Orthopedic · 236d
Cleared May 15, 1995
APOFIX CERVICAL SPINE FIXATION
K945022
Sofamor Co.
Orthopedic · 214d
Cleared Feb 01, 1995
AME UNIVERSAL FIXATION SYSTEM
K931381
American Medical Electronics, Inc.
Orthopedic · 685d
Cleared Oct 19, 1994
J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE
K935113
J.B.S., S.A.
Orthopedic · 359d
Cleared Sep 01, 1994
STRYKER 2S SPINAL SYSTEM
K930009
Stryker Corp.
Orthopedic · 605d
Cleared Jul 12, 1994
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881
Depuy, Inc.
Orthopedic · 336d
Cleared Jun 29, 1994
ALPHA SPINAL SYSTEM
K930515
Alphatec Mfg., Inc.
Orthopedic · 513d
Cleared Jun 29, 1994
D-C-S SYSTEM
K930657
Pina-Vertriebs
Orthopedic · 505d
Cleared Jun 21, 1994
GDLH VARIABLE ANGLE CONNECTOR
K934582
Danek Group, Inc.
Orthopedic · 271d
Cleared Jun 03, 1994
TI-FRAME
K934860
Johnson & Johnson Professionals, Inc.
Orthopedic · 234d
Cleared Jun 02, 1994
SOFAMOR ORFIL SPINE FIXATION SYSTEM
K934007
Sofamor Co.
Orthopedic · 288d
Cleared May 04, 1994
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205
Danek Medical, Inc.
Orthopedic · 307d
Cleared May 02, 1994
LOW PROFILE MID CROSS BRACING
K931225
Advanced Spine Fixation Systems, Inc.
Orthopedic · 418d
Cleared Apr 29, 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891
Synthes (Usa)
Orthopedic · 431d
Cleared Mar 28, 1994
BRYAN SPINAL FIXATER (BSF)
K914548
Arcan Orthopaedic Corp.
Orthopedic · 899d
Cleared Mar 28, 1994
LOW PROFILE SLEAVE NUT ASSEMBLY
K931208
Advanced Spine Fixation Systems, Inc.
Orthopedic · 383d