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Sign in to claim this brandAscension Orthopedics, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 11101 Metric Blvd, Austin, TX, 78758
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3002788818
- DUNS Number
- —
Catalogue (4000)
Page 79 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| K2™ Hemi Toe Implant System | 205002 | FDA UDI | Class I | Unknown |
| Titan™ | INS-0961-049-01 | FDA UDI | Class I | Active |
| Salto Talaris® | MJU652T | FDA UDI | Class I | Active |
| Integra® Proximal Humeral Fracture Plate System | PSS3522LS | FDA UDI | Class II | Active |
| Cadence® | 10208211 | FDA UDI | Class II | Active |
| Cadence™ | 10207211 | FDA UDI | Class II | Active |
| Integra® Total Wrist Fusion System | 303101S | FDA UDI | Class II | Unknown |
| Salto Talaris® | MJU662T | FDA UDI | Class I | Active |
| Integra® Spider™ Limted Wrist Fusion System | 600719 | FDA UDI | Class I | Active |
| Titan™ | S095002514125 | FDA UDI | Class II | Unknown |
| Salto Talaris® | MJU667T | FDA UDI | Class I | Active |
| Ti6® Internal Fixation System | FS2003 | FDA UDI | Class I | Active |
| Integra® Ti6® Internal Fixation System | TS4036 | FDA UDI | Class II | Active |
| Integra® Ti6® Internal Fixation System | TS4032 | FDA UDI | Class II | Active |
| Integra®Ti6® | TH2514 | FDA UDI | Class II | Active |
| Katalyst™ Bipolar Radial Head System | 225924 | FDA UDI | Class II | Active |
| Integra® Freedom Wrist Arthroplasty System | 348105 | FDA UDI | Class I | Active |
| Universal 2™ Total Wrist System | 263700RT | FDA UDI | Class II | Unknown |
| Integra™Allograft Wedge System | 390008 | FDA UDI | Class I | Active |
| Titan™ Total Shoulder System | B92002010LRG | FDA UDI | Class II | Active |
| Integra® Total Foot System | 2807002 | FDA UDI | Class II | Unknown |
| CAPTURE™ High Torque Screw System | CSS50000052514T | FDA UDI | Class II | Active |
| Construct® Ankle Fusion Plate System | PSS4540LT | FDA UDI | Class II | Unknown |
| Integra® Pyrosphere® | CSA44003 | FDA UDI | Class I | Active |
| Integra® NuGrip® | TRL44330L | FDA UDI | Class II | Active |
| Integra® Freedom Wrist Arthroplasty System | 348340E | FDA UDI | Class II | Active |
| Cadence™ | 10205002 | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS50000043024T | FDA UDI | Class II | Active |
| Integra® Proximal Humeral Fracture Plate System | HFP0930109LS | FDA UDI | Class II | Active |
| Salto Talaris® | MJU953T | FDA UDI | Class I | Active |
| Cadence™ | 10209440 | FDA UDI | Class II | Active |
| Titan™ | TRL096005E | FDA UDI | Class II | Active |
| Titan™ | PEG-0926-000 | FDA UDI | Class I | Active |
| Cadence™ | 10209161 | FDA UDI | Class II | Active |
| Integra® Total Foot System | 2845140 | FDA UDI | Class II | Active |
| Integra® Total Foot System | 2808306 | FDA UDI | Class II | Active |
| Viper® Distal Volar Radius Plating System | 605227 | FDA UDI | Class I | Unknown |
| Titan™ | CSA-0923-01 | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS50000025034T | FDA UDI | Class II | Active |
| Cadence™ | 10206112 | FDA UDI | Class I | Active |
| KGTI™ Kinetik Great Toe Implant System | 015090 | FDA UDI | Class I | Unknown |
| Titan™ | SCW-0961-046-55 | FDA UDI | Class II | Active |
| Integra® Total Foot System | 2822006 | FDA UDI | Class II | Active |
| Construct® Ankle Fusion Plate System | PSS6550CT | FDA UDI | Class II | Unknown |
| Integra® BioMotion® Cannulated Hemi System | HM1900 | FDA UDI | Class II | Active |
| Titan™ | T92002010SML | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS50000034048T | FDA UDI | Class II | Active |
| Salto Talaris® | MJU335T | FDA UDI | Class I | Active |
| Salto Talaris® | MJU357T | FDA UDI | Class I | Active |
| Integra® XT | LJU272T | FDA UDI | Class II | Active |
Related Companies
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Importers
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 16, 2018 | Z-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, 2011 | Z-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, 2010 | Z-0438-2011 | — | terminated | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. |
| Jul 12, 2010 | Z-0437-2011 | — | terminated | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. |
| Jun 17, 2009 | Z-1524-2010 | — | terminated | Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant. |
| Apr 14, 2009 | Z-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, 2003 | Z-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, 2002 | Z-0549-03 | — | terminated | Brochures approved for international distribution only were distributed domestically. |
| Oct 31, 2002 | Z-0550-03 | — | terminated | Literature approved for international distribution only was distributed domestically. |