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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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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3002788818
- DUNS Number
- —
Catalogue (4000)
Page 8 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Integra® | 2237811 | FDA UDI | Class I | Active |
| CAPTURE™ Screw System | AC3020 | FDA UDI | Class II | Active |
| Integra® Total Foot System | 2830045 | FDA UDI | Class II | Active |
| K2™ Hemi Toe Implant System | 203030 | FDA UDI | Class I | Unknown |
| Integra® | 12224300 | FDA UDI | Class I | Active |
| Panta® 2 | PAN-1010-0190 | FDA UDI | Class I | Active |
| Integra® MemoFix® | MS121916 | FDA UDI | Class II | Active |
| Panta® 2 | PAN-1010-0014 | FDA UDI | Class I | Active |
| Titan™ | CVR0920077L | FDA UDI | Class I | Active |
| Integra® External Fixation System | 12225400 | FDA UDI | Class II | Active |
| DigiFuse® Cannulated Intramedullary Fusion System | DF2670 | FDA UDI | Class I | Active |
| CAPTURE™ Screw System | AC4028 | FDA UDI | Class II | Active |
| Titan™ Total Shoulder System | B92002010SML | FDA UDI | Class II | Active |
| Integra® Proximal Humeral Fracture Plate System | HFP0930310RS | FDA UDI | Class II | Active |
| Ascension® Silicone MCP | SMCP50020WW | FDA UDI | Class II | Active |
| Cadence™ | 10204089 | FDA UDI | Class I | Active |
| Titan™ Total Shoulder System | MHH-0923-010-4416E | FDA UDI | Class II | Active |
| Cadence™ | 10209336 | FDA UDI | Class II | Active |
| Integra® XT | LJV308T | FDA UDI | Class II | Active |
| Integra®Ti6® | TQ2720 | FDA UDI | Class II | Active |
| Integra® Ti6® Internal Fixation System | TS2522 | FDA UDI | Class II | Active |
| Integra® Total Foot System | 2814006 | FDA UDI | Class II | Active |
| Integra® Ti6® Internal Fixation System | TS4012 | FDA UDI | Class II | Active |
| Universal 2™ Total Wrist System | 263200RT | FDA UDI | Class II | Active |
| Integra® | TRL71504T | FDA UDI | Class II | Active |
| Panta® 2 | PAN-1010-1665 | FDA UDI | Class II | Unknown |
| Salto Talaris® | LJU410T | FDA UDI | Class II | Active |
| Cadence™ | 10209309 | FDA UDI | Class II | Active |
| Integra® Freedom Wrist Arthroplasty System | 348001E | FDA UDI | Class II | Active |
| Titan™ | DRL-0926-018-S | FDA UDI | Class I | Active |
| Integra® Spider™ Limted Wrist Fusion System | 072810 | FDA UDI | Class II | Active |
| Integra® External Fixation System | 12224241 | FDA UDI | Class II | Active |
| Integra® Ti6® Internal Fixation System | DS2030 | FDA UDI | Class II | Active |
| Integra® MOVEMENT® Great Toe System | MGT89030MT | FDA UDI | Class II | Active |
| Construct ™ | GTB-1000-02 | FDA UDI | Class I | Unknown |
| Cadence™ | 10209459 | FDA UDI | Class II | Active |
| Integra® | PBH80001 | FDA UDI | Class I | Active |
| bioBLOCK® Subtalar Implant System | 040010 | FDA UDI | Class II | Active |
| Integra® | CSA100107 | FDA UDI | Class I | Active |
| Integra® Total Wrist Fusion System | 303218CS | FDA UDI | Class II | Active |
| Integra® Total Wrist Fusion System | 303450 | FDA UDI | Class I | Active |
| Cadence® | 10200111 | FDA UDI | Class II | Active |
| Capture™ | CND-5000-502-070 | FDA UDI | Class I | Active |
| Capture™ | CSA-5000-011 | FDA UDI | Class I | Active |
| Ascension® | TRL50010 | FDA UDI | Class II | Active |
| Integra® Total Wrist Fusion System | 303322CS | FDA UDI | Class II | Active |
| Cadence™ | 10209252 | FDA UDI | Class II | Active |
| Integra™Allograft Wedge System | WEDGEINST | FDA UDI | Class I | Unknown |
| Universal 2™ Total Wrist Implant System | 268231 | FDA UDI | Class I | Active |
| Cadence® | 10200104 | FDA UDI | Class II | 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. |