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Ascension Orthopedics, Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
11101 Metric Blvd, Austin, TX, 78758
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3002788818
DUNS Number
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Catalogue (4000)

Page 6 of 80
DeviceModel / ReferenceRegistriesClassStatus
Integra®Ti6® TC2522
FDA UDI
Class IIActive
Titan™ Total Shoulder System M9200104419E
FDA UDI
Class IIActive
Integra® CGT-40T
FDA UDI
Class IIActive
Capture™ AW-3005
FDA UDI
Class IActive
Titan™ TITANREVSPBIMP
FDA UDI
Class IUnknown
Salto Talaris® YKAL55T
FDA UDI
Class IUnknown
Integra® Freedom Wrist Arthroplasty System 348178
FDA UDI
Class IActive
Panta® 2 Arthrodesis Nail System PAN-1010-2665NS
FDA UDI
Class IIActive
Salto Talaris® MJU558T
FDA UDI
Class IActive
Integra® XT LJV160T
FDA UDI
Class IIActive
Cadence™ 10209409
FDA UDI
Class IIActive
Movement® TRL89020PPT
FDA UDI
UActive
Integra® CSA-000-06
FDA UDI
Class IActive
Integra® Freedom Wrist Arthroplasty System 348070
FDA UDI
Class IActive
First Choice® DRUJ System CSA61001
FDA UDI
Class IActive
Cadence™ 10209138
FDA UDI
Class IIActive
Integra® 12224029
FDA UDI
Class IActive
Titan™ TRL096005C
FDA UDI
Class IIActive
Titan™ HSP-0923-070-005
FDA UDI
Class IActive
Cadence® 10208212
FDA UDI
Class IIActive
Cadence™ 10207105
FDA UDI
Class IIActive
Viper® Distal Volar Radius Plating System 27142714
FDA UDI
Class IIUnknown
Integra® Total Foot System 2833035
FDA UDI
Class IIActive
Integra®Ti6® FS4010
FDA UDI
Class IActive
Integra® NuGrip® SHP443L
FDA UDI
Class IActive
Universal 2™ Total Wrist System 263300LF
FDA UDI
Class IIActive
Integra® CCR8950224
FDA UDI
Class IActive
Integra® Total Foot System 2812003
FDA UDI
Class IIActive
Salto Talaris® MJU345T
FDA UDI
Class IActive
Movement® CSA-890-10
FDA UDI
Class IActive
Viper® Distal Volar Radius Plating System 270012
FDA UDI
Class IUnknown
Integra® First Choice® TRL600H175
FDA UDI
Class IIActive
Titan™ TRL-0923-021-08STD
FDA UDI
Class IActive
Panta® 2 PAN-1010-1444NS
FDA UDI
Class IIActive
Universal 2™ Total Wrist Implant System 268430R
FDA UDI
Class IActive
Integra®Ti6® TT4000L
FDA UDI
Class IActive
K2™ Hemi Toe Implant System 203100
FDA UDI
Class IUnknown
Titan™ Total Shoulder System BOD-0923-020-14LRG
FDA UDI
Class IIActive
Integra® Total Wrist Fusion System 303403
FDA UDI
Class IActive
Integra® Total Foot System" TFSFOREFTIMP
FDA UDI
Class IIUnknown
Ascension® CSA-500-01
FDA UDI
Class IUnknown
TiWedge™ TRL-1006-L02
FDA UDI
Class IIUnknown
Titan™ TRL096008SML
FDA UDI
Class IActive
Cadence™ 10209218
FDA UDI
Class IIActive
Universal 2™ Total Wrist System 263400RT
FDA UDI
Class IIActive
Panta® 2 PAN-1010-0011
FDA UDI
Class IActive
Cadence™ 10204181
FDA UDI
Class IActive
CAPTURE™ Screw System AC3024
FDA UDI
Class IIActive
Integra®Ti6® TC3010
FDA UDI
Class IIActive
Viper® Distal Volar Radius Plating System 27142732
FDA UDI
Class IIUnknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Nov 16, 2018Z-0794-2019—terminated

The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).

Dec 3, 2011Z-1060-2012—terminated

A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filing with the FDA.

Jul 12, 2010Z-0438-2011—terminated

Two different product lots were found to be incorrectly labeled and placed into the incorrect box.

Jul 12, 2010Z-0437-2011—terminated

Two different product lots were found to be incorrectly labeled and placed into the incorrect box.

Jun 17, 2009Z-1524-2010—terminated

Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.

Apr 14, 2009Z-1524-2009—terminated

Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.

Oct 2, 2003Z-1025-04—terminated

Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.

Oct 31, 2002Z-0549-03—terminated

Brochures approved for international distribution only were distributed domestically.

Oct 31, 2002Z-0550-03—terminated

Literature approved for international distribution only was distributed domestically.