Medical Device Manufacturer · US , Malwah , NJ

Stryker Orthopaedics - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2004
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stryker Orthopaedics Orthopedic
24 devices
1-24 of 24
Cleared Aug 16, 2021
Insignia Hip Stem
K211703 · MEH
Orthopedic · 74d
Cleared Aug 28, 2019
EXETER Centralizer, EXETER 2.5mm Plug
K191414 · JDI
Orthopedic · 92d
Cleared Mar 19, 2018
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
K173499 · JDG
Orthopedic · 126d
Cleared Feb 02, 2018
Triathlon Total Knee System
K173849 · MBH
Orthopedic · 45d
Cleared Oct 30, 2017
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
K172326 · JWH
Orthopedic · 90d
Cleared May 25, 2016
Stryker Orthopaedics Hip Systems Labeling Update
K153345 · LPH
Orthopedic · 188d
Cleared Aug 10, 2015
Restoration Anatomic Shell
K151264 · LPH
Orthopedic · 89d
Cleared Feb 09, 2015
Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip...
K143085 · LPH
Orthopedic · 105d
Cleared Jan 13, 2015
Triathlon Tritanium Cone Augments
K143393 · MBH
Orthopedic · 48d
Cleared Nov 14, 2014
Restoration Anatomic Shell
K142462 · LPH
Orthopedic · 73d
Cleared Aug 05, 2014
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
K141056 · MBH
Orthopedic · 103d
Cleared Nov 26, 2013
TRIATHLON TRITANIUM METAL-BACKED PATELLA
K132624 · MBH
Orthopedic · 96d
Cleared Jan 07, 2008
TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
K072575 · MBH
Orthopedic · 116d
Cleared Mar 02, 2007
DALL-MILES SYSTEM
K070170 · HRS
Orthopedic · 43d
Cleared Feb 02, 2007
PCA ALUMINA FEMORAL HEADS
K063816 · LZO
Orthopedic · 42d
Cleared Jan 25, 2007
MODIFICATION TO HIPSTAR FEMORAL STEM
K063822 · LPH
Orthopedic · 30d
Cleared Jan 08, 2007
SIMPLEX P BONE CEMENT
K062553 · LOD
Orthopedic · 131d
Cleared May 10, 2006
HIPSTAR FEMORAL STEM
K051223 · LZO
Orthopedic · 363d
Cleared Jan 26, 2006
TRIATHLON TOTAL KNEE SYSTEM
K053514 · JWH
Orthopedic · 41d
Cleared Jan 13, 2006
SHORT CITATION FEMORAL STEM
K053528 · MEH
Orthopedic · 25d
Cleared Sep 27, 2005
ACCOLADE RPS HIP STEM
K052542 · LZO
Orthopedic · 12d
Cleared Sep 26, 2005
ACCOLADE HFX FEMORAL STEM
K051741 · LZO
Orthopedic · 90d
Cleared Jan 07, 2005
SOLAR 2 ANATOMIC SHOULDER
K040432 · HSD
Orthopedic · 323d
Cleared May 25, 2004
TRIDENT T ACETABULAR SHELLS
K040412 · LPH
Orthopedic · 97d
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