Data / Medical devices / France / Imascap
Imascap: FDA-registered device maker in PLOUZANE Finistere, France, 7 510(k) clearances
Imascap is registered with the FDA (registration 3014027736) in PLOUZANE Finistere, France. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 3, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014027736
- Address
- 65 place Nicolas Copernic, PLOUZANE Finistere, France, 29280
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Specification developer
- First device listed
- April 23, 2021
- Registered through
- 2027
- Brand names listed
- BLUEPRINT Patient Specific Instrumentation, BluePrint, Blueprint, Blueprint Patient-Specific Instrumentation, Blueprint Patient Specific Instrumentation, Shoulder iD, Shoulder iD Primary Reversed Glenoid, Tornier Perform Patient-Matched Primary Reversed Glenoid
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 2 | Specification developer | accessdata.fda.gov |
| Shoulder Arthroplasty Implantation System | QHE | 2 | Specification developer | accessdata.fda.gov |
| Shoulder Prosthesis, Reverse Configuration | PHX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 3, 2026 | K253674 | Blueprint Patient-Specific Instrumentation | PHX | Substantially Equivalent | Stryker Corporation (Tornier, S.A.S.) | accessdata.fda.gov |
| February 21, 2024 | K232265 | BLUEPRINT Patient Specific Instrumentation | PHX | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| November 12, 2021 | K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| February 22, 2017 | K162800 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| December 27, 2016 | K161789 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| June 10, 2016 | K160555 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| April 8, 2015 | K143374 | BLUEPRINT Patient Specific Instrumentation | KWS | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
Compare with other makers
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Shoulder Arthroplasty Implantation System
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Updated April 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.