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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
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EUDAMED SRN
—
FDA FEI Number
3002788818
DUNS Number
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Catalogue (4000)

Page 2 of 80
DeviceModel / ReferenceRegistriesClassStatus
Titan™ DDG096007701
FDA UDI
Class IActive
Movement® CSA-890-11
FDA UDI
Class IActive
TiWedge™ TRL-1006-L03
FDA UDI
Class IIUnknown
Cadence® 10200213
FDA UDI
Class IIActive
Salto Talaris® CSA-1030-0005
FDA UDI
Class IActive
Kompressor™ Compression Screw System 217414
FDA UDI
Class IUnknown
KGTI™ Kinetik Great Toe Implant System 015032
FDA UDI
Class IUnknown
Integra® Ti6® Internal Fixation System TS2508
FDA UDI
Class IIActive
CAPTURE™ High Torque Screw System CSS50000025036T
FDA UDI
Class IIActive
Universal 2™ Total Wrist Implant System 267200LF
FDA UDI
Class IActive
Salto Talaris® LJU229T
FDA UDI
Class IIActive
Panta® 2 PAN-1010-1480NS
FDA UDI
Class IIActive
Titan™ TRL096002C
FDA UDI
Class IIActive
Cadence™ 10209308
FDA UDI
Class IIActive
Movement® TRL89040PPT
FDA UDI
UActive
Cadence™ 10203002
FDA UDI
Class IUnknown
Integra® Freedom Wrist Arthroplasty System 348043
FDA UDI
Class IActive
Movement® PSR-890-10/20
FDA UDI
Class IActive
Salto Talaris® LJU247T
FDA UDI
Class IIActive
Panta® 2 Arthrodesis Nail System PAN-1010-2670NS
FDA UDI
Class IIActive
Salto Talaris® LJU421T
FDA UDI
Class IIActive
Cadence™ 10209561
FDA UDI
Class IIActive
Capture™ CSA-5000-008
FDA UDI
Class IActive
Titan™ MON-0927-026-11
FDA UDI
Class IActive
Panta® 2 PAN-1010-1700
FDA UDI
Class IIUnknown
Salto Talaris® MJU617T
FDA UDI
Class IActive
Cadence™ 10203024
FDA UDI
Class IActive
CAPTURE™ High Torque Screw System CSS500000670WT
FDA UDI
Class IIActive
Integra® Proximal Humeral Fracture Plate System PSS3535LS
FDA UDI
Class IIActive
Integra® CSA-805-01
FDA UDI
Class IUnknown
MBA™ Titanium Subtalar Implant System 050209
FDA UDI
Class IActive
Integra® 8053-023NS
FDA UDI
Class IUnknown
Cadence™ 10204217
FDA UDI
Class IActive
Integra® Titanium Bone Wedge System TBW-1006-2055
FDA UDI
Class IIUnknown
Cadence® 10204287
FDA UDI
Class IActive
Cadence™ 10209346
FDA UDI
Class IIActive
Integra® Total Wrist Fusion System 303409
FDA UDI
Class IActive
Integra® Freedom Wrist Arthroplasty System 348002E
FDA UDI
Class IIActive
Ascension PIP PIP-200-20D-WW
FDA UDI
UnclassifiedActive
Universal 2™ Total Wrist System 261101
FDA UDI
Class IIActive
Salto Talaris® LJU201T
FDA UDI
Class IIActive
Kompressor™ KOMPSET
FDA UDI
Class IIUnknown
Cadence™ 10209130
FDA UDI
Class IIActive
Titan™ CSA092021
FDA UDI
Class IActive
Integra® A3020
FDA UDI
Class IActive
CAPTURE™ Screw System AC4030
FDA UDI
Class IIActive
Titan™ CSA096001
FDA UDI
Class IActive
Integra®Ti6® FS3040
FDA UDI
Class IActive
Kompressor™ Compression Screw System 211501
FDA UDI
Class IUnknown
Integra® External Fixation System 12220040
FDA UDI
Class IIActive

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.