Medical Device Manufacturer · US , Austin , TX

Ascension Orthopedic - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2011

Recent clearances: INTEGRA EXTERNAL FIXATION SYSTEM, INTEGRA TITANIUM BONE WEDGE, TITAN REVERSE SHOULDER SYSTEM

View 7 510(k) Devices ↓
7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Ascension Orthopedic Orthopedic ✕

7 devices
1-7 of 7
Cleared Oct 10, 2014
INTEGRA EXTERNAL FIXATION SYSTEM
K140463 · KTT
Orthopedic · 228d
Cleared Aug 07, 2013
INTEGRA TITANIUM BONE WEDGE
K131360 · HRS
Orthopedic · 86d
Cleared Jun 18, 2013
TITAN REVERSE SHOULDER SYSTEM
K130050 · KWS
Orthopedic · 160d
Cleared Apr 11, 2012
TITAN MODULAR TOTAL SHOULDER SYSTEM
K112438 · KWS
Orthopedic · 231d
Cleared Apr 09, 2012
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
K112481 · KXE
Orthopedic · 224d
Cleared Nov 04, 2011
ASCENSION NUGRIP CMC IMPLANT
K112278 · KYI
Orthopedic · 87d
Cleared Aug 19, 2011
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
K111799 · HWC
Orthopedic · 53d
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