ClearanceBrief
Company ยท US

Ascension Orthopedic

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2014. Name variants (Inc, Corp, punctuation) are merged.

7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2
HRSPlate, Fixation, Bone1
HWCScrew, Fixation, Bone1
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1
KXEProsthesis, Wrist, Hemi-, Ulnar1
KYIProsthesis, Wrist, Carpal Trapezium1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 10, 2014K140463INTEGRA EXTERNAL FIXATION SYSTEM
Ascension Orthopedic
KTT
Aug 7, 2013K131360INTEGRA TITANIUM BONE WEDGE
Ascension Orthopedic
HRS
Jun 18, 2013K130050TITAN REVERSE SHOULDER SYSTEM
Ascension Orthopedic
KWS
Apr 11, 2012K112438TITAN MODULAR TOTAL SHOULDER SYSTEM
Ascension Orthopedic
KWS
Apr 9, 2012K112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
Ascension Orthopedic
KXE
Nov 4, 2011K112278ASCENSION NUGRIP CMC IMPLANT
Ascension Orthopedic
KYI
Aug 19, 2011K111799NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
Ascension Orthopedic
HWC

Latest recalls

DateFirm and productCodeLinked 510(k)
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