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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 10 of 80
DeviceModel / ReferenceRegistriesClassStatus
Integra® NuGrip® TRL44320M
FDA UDI
Class IIActive
Viper® Distal Volar Radius Plating System 27142720
FDA UDI
Class IIUnknown
Integra™CMC Interpositional Sizer 322121
FDA UDI
Class IUnknown
Titan™ T9200103814E
FDA UDI
Class IActive
Construct® Ankle Fusion Plate System PSS4518CT
FDA UDI
Class IIUnknown
Integra® Spider™ Limted Wrist Fusion System 600718
FDA UDI
Class IActive
Integra® HTG093003L
FDA UDI
Class IActive
Cadence® 10204285
FDA UDI
Class IActive
Capture™ CSA-5000-012
FDA UDI
Class IActive
Titan™ Total Shoulder System BSH-0923-048-002
FDA UDI
Class IActive
Cadence™ 10209248
FDA UDI
Class IIActive
Titan™ IMP096007101
FDA UDI
Class IActive
Integra® FGT-305T
FDA UDI
Class IActive
Titan™ RMR-0926-01N
FDA UDI
Class IActive
Construct ™ TSS-5010-01
FDA UDI
Class IActive
Integra® LDGTFS25
FDA UDI
Class IActive
Movement® TRL89040MT
FDA UDI
Class IIActive
Integra® Freedom Wrist Arthroplasty System 348297
FDA UDI
Class IIActive
Ascension® TRL50030
FDA UDI
Class IIActive
Titan™ Total Shoulder System MHH-0923-010-4815E
FDA UDI
Class IIActive
Integra® XT LJV163T
FDA UDI
Class IIActive
Titan™ BDG-0961-074-S
FDA UDI
Class IActive
Titan™ IMP-0926-030-01A
FDA UDI
Class IActive
Cadence™ 10209137
FDA UDI
Class IIActive
Ascension® First Choice® DRUJ System MUH600S55LWW
FDA UDI
Class IIActive
Salto Talaris® DWD060T
FDA UDI
Class IActive
Salto Talaris® YKAL56T
FDA UDI
Class IUnknown
Titan™ GLN-0926-030-01A
FDA UDI
Class IIActive
Ascension® MCP MCP10040DWW
FDA UDI
Class IIIActive
Cadence™ 10204180
FDA UDI
Class IActive
Salto Talaris® MJU635T
FDA UDI
Class IActive
Panta® 2 PAN-1010-1418
FDA UDI
Class IIUnknown
Integra® CTD90002
FDA UDI
Class IActive
CAPTURE™ Screw System AC4020
FDA UDI
Class IIActive
Integra® Total Foot System 2815001
FDA UDI
Class IIActive
Integra® Freedom Wrist Arthroplasty System 348296E
FDA UDI
Class IIActive
Cadence™ 10209148
FDA UDI
Class IIActive
Titan™ DRL-0926-002
FDA UDI
Class IActive
Movement® TRL89020MT
FDA UDI
Class IIActive
Movement® IMP-890-00MT
FDA UDI
Class IActive
Integra® MHT-LGTHT
FDA UDI
Class IActive
Integra® CCR8950221
FDA UDI
Class IActive
Panta® 2 PAN-1010-1456NS
FDA UDI
Class IIActive
Cadence™ 10208103
FDA UDI
Class IIActive
Cadence™ 10209156
FDA UDI
Class IIActive
Cadence™ 10208204
FDA UDI
Class IIActive
Integra® CCR8950219
FDA UDI
Class IActive
Integra® Total Foot System 2835008
FDA UDI
Class IIActive
Titan™ IP0920055001
FDA UDI
Class IActive
Salto Talaris® LJU249T
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.