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

Stryker Orthopaedics has 24 FDA 510(k) cleared orthopedic devices. Based in Malwah, US.

Last cleared in 2021. Active since 2004.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as regulatory consultant.

FDA 510(k) Regulatory Record - Stryker Orthopaedics
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
Filters
Filter by Specialty
All24 Orthopedic 24