Atlas FDA

THOR ANTERIOR PLATING SYSTEM

FDA 510(k) clearance K073437 · decided 2008-02-13

Clearance details

K-number
K073437
Device name
THOR ANTERIOR PLATING SYSTEM
Applicant
Stryker Spine
Decision
Substantially Equivalent
Date received
2007-12-06
Decision date
2008-02-13
Days to decision
69 days
Clearance type
Traditional
Product code
KWQ
Device class
2
Regulation number
888.3060
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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PathLoc Lumbar Plate System (K251940)L&K BIOMED Co., Ltd.2026-03-03
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Lumbar Spine Truss System - Plating Solution (LSTS-PS) (K253201)4Web, Inc.2026-02-12
aprevo® cervical plating system (K252611)Carlsmed, Inc.2025-12-22
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Recalls involving this device

RecordFirmDate
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 25MM, spinal i recall (Z-0424-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 28MM, spinal i recall (Z-0425-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 31MM, spinal i recall (Z-0426-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 34MM, spinal i recall (Z-0427-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 37MM, spinal i recall (Z-0428-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 40MM, spi recall (Z-0429-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 43MM, spi recall (Z-0430-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 46MM, spi recall (Z-0431-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 49MM, spi recall (Z-0432-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 52MM, spi recall (Z-0433-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 55MM, spi recall (Z-0434-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 58MM, spi recall (Z-0435-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 61MM, spi recall (Z-0436-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 64MM, spi recall (Z-0437-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 67MM, spi recall (Z-0438-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 22MM, spinal i recall (Z-0439-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 25MM, spinal i recall (Z-0440-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 28MM, spinal i recall (Z-0441-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 31MM, spinal i recall (Z-0442-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 34MM, spinal i recall (Z-0443-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 37MM, spinal i recall (Z-0444-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 40MM, spi recall (Z-0445-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 43MM, spi recall (Z-0446-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 46MM, spi recall (Z-0447-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 49MM, spi recall (Z-0448-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 52MM, spi recall (Z-0449-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 55MM, spi recall (Z-0450-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 58MM, spi recall (Z-0451-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 61MM, spi recall (Z-0452-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM, spi recall (Z-0453-2010)Stryker Spine2009-11-24
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 67MM, spi recall (Z-0454-2010)Stryker Spine2009-11-24

PMA approvals by this applicant

RecordFirmDate
RAY TFC AND RAY TFC UNITE (P950019/S014)Stryker Spine2004-03-25
RAY TFC UNITE (P950019/S016)Stryker Spine2003-10-10
RAY THREADED FUSION CAGE (TFC) (P950019/S015)Stryker Spine2003-09-04
RAY TFC UNITE PRODUCT LINE (P950019/S013)Stryker Spine2003-07-15
RAY TFC DEVICE/RAY TFC UNITE DEVICE (P950019/S012)Stryker Spine2002-04-02
RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION (P950019/S011)Stryker Spine2000-03-30
RAY TFC DEVICE AND RAY TFC UNITE DEVICE (P950019/S009)Stryker Spine2000-03-02
RAY THREADED FUSION CAGE(TFC) (P950019/S010)Stryker Spine1999-12-01