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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 78 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Titan™ | INS096004901 | FDA UDI | Class I | Active |
| Cadence™ | 10209159 | FDA UDI | Class II | Active |
| Salto Talaris® | MJU337T | FDA UDI | Class I | Active |
| Universal 2™ Total Wrist Implant System | 266100 | FDA UDI | Class I | Active |
| Salto Talaris® | MJV950T | FDA UDI | Class I | Active |
| Construct® Ankle Fusion Plate System | PSS4575CT | FDA UDI | Class II | Unknown |
| Salto Talaris® | LJU411T | FDA UDI | Class II | Active |
| Titan™ Reverse Shoulder System | GLS096002C | FDA UDI | Class II | Active |
| Integra® Freedom Wrist Arthroplasty System | 348325 | FDA UDI | Class II | Active |
| Integra® Total Wrist Fusion System | 303102S | FDA UDI | Class II | Unknown |
| KGTI™ Kinetik Great Toe Implant System | 012002 | FDA UDI | U | Unknown |
| Titan™ | RMR-0961-075-S | FDA UDI | Class I | Active |
| Cadence™ | 10206507 | FDA UDI | Class I | Active |
| Cadence™ | 10209518 | FDA UDI | Class II | Active |
| Cadence™ | 10204126 | FDA UDI | Class I | Unknown |
| Panta® 2 Arthrodesis Nail System | PAN-1010-2650NS | FDA UDI | Class II | Active |
| Cadence® | 10208114 | FDA UDI | Class II | Active |
| Titan™ | HG0920041002 | FDA UDI | Class I | Active |
| Titan™ | TRL-0923-010-5022E | FDA UDI | Class I | Active |
| K2™ Hemi Toe Implant System | 205001 | FDA UDI | Class I | Unknown |
| Titan™ | LNR-0960-192-0R | FDA UDI | Class II | Active |
| Cadence® | 10204272 | FDA UDI | Class I | Active |
| Salto Talaris® | MJU597T | FDA UDI | Class I | Active |
| Titan™ | TRL096006R | FDA UDI | Class II | Active |
| Cadence™ | 10209147 | FDA UDI | Class II | Active |
| Construct® Ankle Fusion Plate System | PSS4565LT | FDA UDI | Class II | Unknown |
| Salto Talaris® | MJU654T | FDA UDI | Class I | Active |
| Cadence™ | 10207213 | FDA UDI | Class II | Active |
| Integra® Total Wrist Fusion System | 303222 | FDA UDI | Class II | Active |
| Salto Talaris® | LJU218T | FDA UDI | Class II | Active |
| Integra® Total Foot System | 2805006 | FDA UDI | Class II | Unknown |
| Integra® Freedom Wrist Arthroplasty System | 348320E | FDA UDI | Class II | Active |
| Cadence™ | 10209417 | FDA UDI | Class II | Active |
| Titan™ | TRL096000R | FDA UDI | Class II | Active |
| Salto Talaris® | LJU217T | FDA UDI | Class II | Active |
| Titan™ | GLN-0926-030-03A | FDA UDI | Class II | Active |
| Integra® Total Wrist Fusion System | 303510 | FDA UDI | Class I | Active |
| Integra® Total Wrist Fusion System | 303222CS | FDA UDI | Class II | Active |
| Panta® 2 | PAN-1010-1470NS | FDA UDI | Class II | Active |
| Titan™ | S95002510125 | FDA UDI | Class II | Active |
| Integra® Spider™ Limted Wrist Fusion System | 075023 | FDA UDI | Class I | Unknown |
| Titan™ | IMP096006401 | FDA UDI | Class I | Active |
| Integra® First Choice® | TRL600LNG | FDA UDI | Class II | Active |
| Cadence® | CSA00019 | FDA UDI | Class II | Active |
| Panta® 2 | PAN-1010-1680 | FDA UDI | Class II | Unknown |
| Integra® Freedom Wrist Arthroplasty System | 348217E | FDA UDI | Class II | Active |
| Panta® 2 | PAN-1010-1428 | FDA UDI | Class II | Unknown |
| Cadence™ | 10209511 | FDA UDI | Class II | Active |
| Titan™ Total Shoulder System | SEM092002510 | FDA UDI | Class II | Active |
| Integra® XT | LJU273T | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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. |