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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
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Catalogue (4000)
Page 5 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KGTI™ Kinetik Great Toe Implant System | 012014 | FDA UDI | U | Unknown |
| Salto Talaris® | MJU383T | FDA UDI | Class I | Active |
| Capture™ | CTD-5000-512-025 | FDA UDI | Class I | Active |
| Integra® Ti6® Internal Fixation System | DS2034 | FDA UDI | Class II | Active |
| Integra® | TRL20230P | FDA UDI | Class II | Active |
| Integra® Total Foot System | 2822020 | FDA UDI | Class II | Active |
| Construct® Ankle Fusion Plate System | PSS6560CT | FDA UDI | Class II | Unknown |
| Kompressor™ Compression Screw System | 211200 | FDA UDI | Class I | Unknown |
| Integra® External Fixation System | 12224235 | FDA UDI | Class II | Active |
| Construct® Ankle Fusion Plate System | PSS6532CT | FDA UDI | Class II | Unknown |
| Ascension® Modular Radial Head | MRH35020L | FDA UDI | Class II | Active |
| TiWedge™ | TRL-1006-L05 | FDA UDI | Class II | Unknown |
| Integra® | FGT-CG2LT | FDA UDI | Class I | Active |
| Titan™ | T9200104815E | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS50000043040T | FDA UDI | Class II | Active |
| Viper® Distal Volar Radius Plating System | 605004 | FDA UDI | Class I | Unknown |
| MBA™ Titanium Subtalar Implant System | 050017 | FDA UDI | Class I | Active |
| Integra® | TRL35122L | FDA UDI | Class II | Active |
| Cadence™ | 10209509 | FDA UDI | Class II | Active |
| Integra® XT | MJU935T | FDA UDI | Class I | Unknown |
| Integra® | OSG20040PV | FDA UDI | Class I | Active |
| Titan™ | HDS-0920-069-501 | FDA UDI | Class I | Active |
| TiWedge™ | TRL-1006-L01 | FDA UDI | Class II | Unknown |
| Salto Talaris® | LJU259T | FDA UDI | Class II | Active |
| Capture™ | CNT-5000-511-050 | FDA UDI | Class I | Active |
| MemoFix® Super Elastic Nitinol Staple System | MS-2900 | FDA UDI | Class I | Active |
| Integra® | BRH90002 | FDA UDI | Class I | Active |
| Integra® | MRHRMR03 | FDA UDI | Class I | Active |
| Movement® | MIS89000 | FDA UDI | Class II | Active |
| Integra® | TRL31003 | FDA UDI | Class II | Active |
| Ascension® Silicone MCP | SMCP50005WW | FDA UDI | Class II | Active |
| Panta® 2 | PAN-1010-1505 | FDA UDI | Class II | Unknown |
| Integra® | CSA100111 | FDA UDI | Class I | Active |
| Salto Talaris® | LJU097T | FDA UDI | Class I | Active |
| BioMotion® Cannulated 1st MPJ Hemi System | HM 3005 | FDA UDI | Class I | Active |
| Integra® | TRL20230D | FDA UDI | Class II | Active |
| Titan™ | HR0920063001 | FDA UDI | Class I | Active |
| Titan™ | T9200104818C | FDA UDI | Class I | Active |
| CAPTURE™ Screw System | AH2514 | FDA UDI | Class II | Active |
| Integra®Ti6® | TC2518 | FDA UDI | Class II | Active |
| Cadence™ | 10209126 | FDA UDI | Class II | Active |
| First Choice® DRUJ System | BRH-600-S45 | FDA UDI | Class I | Active |
| Integra® BioMotion® | HM3017 | FDA UDI | Class I | Active |
| CAPTURE™ Screw System | AC3030 | FDA UDI | Class II | Active |
| Integra® Total Foot System | 2845118 | FDA UDI | Class II | Active |
| Ascension® PyroSphere | PCS43040WW | FDA UDI | Class II | Active |
| Titan™ | TL092003001K | FDA UDI | Class I | Active |
| Integra® | CSA-805-02 | FDA UDI | Class I | Unknown |
| Ti6® Internal Fixation System | FS2020 | FDA UDI | Class I | Active |
| Titan™ | CSA092025 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
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Importers
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Authorities
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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. |