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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
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3002788818
- DUNS Number
- —
Catalogue (4000)
Page 4 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Movement® | CSA-890-12 | FDA UDI | Class I | Active |
| Integra® Total Foot System | 2808108 | FDA UDI | Class II | Active |
| CAPTURE™ Screw System | AC4040 | FDA UDI | Class II | Active |
| Capture™ | MAT-000-02 | FDA UDI | Class I | Active |
| Cadence™ | 10209407 | FDA UDI | Class II | Active |
| Integra®Ti6® | TC3040 | FDA UDI | Class II | Active |
| Integra® Proximal Humeral Fracture Plate System | PSS3530CS | FDA UDI | Class II | Active |
| Salto Talaris® | MJV423T | FDA UDI | Class I | Active |
| Integra® Total Foot System | 2813008 | FDA UDI | Class II | Active |
| Salto Talaris® | LJV528T | FDA UDI | Class I | Active |
| Integra® | 12225300 | FDA UDI | Class I | Active |
| Cadence™ | 10209551 | FDA UDI | Class II | Active |
| Integra® Freedom Wrist Arthroplasty System | 348330E | FDA UDI | Class II | Active |
| Integra® Freedom Wrist Arthroplasty System | 348281 | FDA UDI | Class I | Active |
| Integra® Total Foot System | 2830012 | FDA UDI | Class II | Active |
| Integra® XT | MJV293T | FDA UDI | Class I | Active |
| Cadence™ | 10209426 | FDA UDI | Class II | Active |
| Salto Talaris® | MJU372T | FDA UDI | Class I | Active |
| Integra® | MRADHDINSTP | FDA UDI | Class II | Unknown |
| Integra® Proximal Humeral Fracture Plate System | HFP0930307RS | FDA UDI | Class II | Active |
| Panta® 2 Arthrodesis Nail System | PAN-1010-2705NS | FDA UDI | Class II | Active |
| Integra® | DRLTFS15 | FDA UDI | Class I | Active |
| Titan™ | TRL-0923-010-5220E | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS50000043020T | FDA UDI | Class II | Active |
| CAPTURE™ Screw System | AC2014 | FDA UDI | Class II | Active |
| CAPTURE™ High Torque Screw System | CSS50000043018T | FDA UDI | Class II | Active |
| Ascension® First Choice® DRUJ System | DRUJ6101965WW | FDA UDI | Class II | Active |
| CAPTURE™ Screw System | AQ2714 | FDA UDI | Class II | Active |
| Salto Talaris® | MJU589T | FDA UDI | Class I | Active |
| Titan™ | T9200105022E | FDA UDI | Class I | Active |
| Integra® | FGT-40T | FDA UDI | Class II | Active |
| Integra® | FGT-LIDT | FDA UDI | Class I | Active |
| Integra® | SHP9005221 | FDA UDI | Class II | Active |
| Integra® | CSA100109 | FDA UDI | Class I | Active |
| Integra® Total Foot System | 2808107 | FDA UDI | Class II | Active |
| CAPTURE™ Screw System | AC4038 | FDA UDI | Class II | Active |
| Cadence™ | 10206109 | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | HITORQ7IMP | FDA UDI | Class II | Unknown |
| Integra® NuGrip® | SHP443M | FDA UDI | Class I | Active |
| Integra®Ti6® | TC2008 | FDA UDI | Class II | Active |
| Ascension® PyroCarbon Lunate | LUN71005WW | FDA UDI | Class II | Active |
| Integra® TruArch® | TA1100 | FDA UDI | Class II | Unknown |
| Integra® MOVEMENT® Great Toe System | MGT89030PPH | FDA UDI | Class II | Active |
| Integra® | CSA093001 | FDA UDI | Class I | Active |
| Cadence™ | 10209140 | FDA UDI | Class II | Active |
| Movement® | TRL89010PPH | FDA UDI | Class II | Active |
| Integra®Ti6® | TT1000 | FDA UDI | Class I | Active |
| Integra® Freedom Wrist Arthroplasty System | 348292E | FDA UDI | Class II | Active |
| Integra® Ti6® Internal Fixation System | TS2006 | FDA UDI | Class II | Active |
| Integra® | 12227005 | FDA UDI | Class I | Active |
Related Companies
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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. |