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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
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- FDA FEI Number
- 3002788818
- DUNS Number
- —
Catalogue (4000)
Page 77 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Panta® 2 | PAN-1010-1480 | FDA UDI | Class II | Unknown |
| Titan™ | CSA-0926-01 | FDA UDI | Class I | Active |
| Construct ™ | PDG-5010-01 | FDA UDI | Class I | Unknown |
| Integra® First Choice® | TRL600S55 | FDA UDI | Class I | Active |
| Kompressor™ Compression Screw System | 217428 | FDA UDI | Class I | Unknown |
| Kompressor™ Compression Screw System | 211601 | FDA UDI | Class I | Unknown |
| MemoFix® Super Elastic Nitinol Staple System | MS-2815 | FDA UDI | Class I | Active |
| Integra® Freedom Wrist Arthroplasty System | 348240E | FDA UDI | Class II | Active |
| Integra® First Choice® | TRL610H190S55 | FDA UDI | Class I | Active |
| Kompressor™ Compression Screw System | 211622 | FDA UDI | Class I | Unknown |
| MemoFix® Super Elastic Nitinol Staple System | MS-2940 | FDA UDI | Class I | Active |
| Cadence™ | 10209522 | FDA UDI | Class II | Active |
| Integra® XT | MJU939T | FDA UDI | Class I | Active |
| Integra® Total Wrist Fusion System | 303102 | FDA UDI | Class II | Active |
| Integra® Proximal Humeral Fracture Plate System | PSS3537CS | FDA UDI | Class II | Active |
| Universal 2™ Total Wrist Implant System | 268100 | FDA UDI | Class I | Active |
| Titan™ | SZR-0926-030-020 | FDA UDI | Class I | Active |
| Cadence™ | 10209420 | FDA UDI | Class II | Active |
| Salto Talaris® | MJU588T | FDA UDI | Class I | Active |
| Titan™ | TRL-0961-02E-S | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS50000017070T | FDA UDI | Class II | Active |
| Integra™Allograft Wedge System | 390006 | FDA UDI | Class I | Active |
| Salto Talaris® | MJU339T | FDA UDI | Class I | Active |
| Panta® 2 Arthrodesis Nail System | PAN-1010-2645NS | FDA UDI | Class II | Active |
| Cadence™ | 10209437 | FDA UDI | Class II | Active |
| Salto Talaris® | LJU409T | FDA UDI | Class II | Active |
| Salto Talaris® | MJU380T | FDA UDI | Class I | Active |
| Integra® XT | LJU426T | FDA UDI | Class II | Active |
| Titan™ | TRL-0923-010-4416C | FDA UDI | Class I | Active |
| Titan™ | TITANG1IMP | FDA UDI | Class II | Unknown |
| Titan™ | TRL-0923-010-4821E | FDA UDI | Class I | Active |
| Panta® 2 Arthrodesis Nail System | PAN-1010-2710NS | FDA UDI | Class II | Active |
| Kompressor™ Compression Screw System | 217424 | FDA UDI | Class I | Unknown |
| Integra® Total Wrist Fusion System | 303320CS | FDA UDI | Class II | Active |
| Cadence™ | 10204176 | FDA UDI | Class I | Active |
| Integra® XT | MJV101T | FDA UDI | Class I | Active |
| Kompressor™ Compression Screw System | 211720 | FDA UDI | Class I | Active |
| Cadence™ | 10209520 | FDA UDI | Class II | Active |
| Salto Talaris® | MJU615T | FDA UDI | Class I | Active |
| Cadence™ | 10203108 | FDA UDI | Class I | Active |
| Titan™ | CSA092024 | FDA UDI | Class I | Active |
| Titan™ | DRL-0926-015-S | FDA UDI | Class I | Active |
| Cadence™ | 10209227 | FDA UDI | Class II | Active |
| Cadence™ | 10209151 | FDA UDI | Class II | Active |
| Cadence™ | 10209531 | FDA UDI | Class II | Active |
| Salto Talaris® | MJU657T | FDA UDI | Class I | Active |
| Cadence™ | 10204186 | FDA UDI | Class I | Active |
| Salto Talaris® | MJU637T | FDA UDI | Class I | Active |
| Titan™ | RMR-0926-03BC | FDA UDI | Class I | Active |
| Integra® XT | MJV426T | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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. |