Tornier Perform® Reversed Glenoid
Ref DWJ150Model 08858251006543TR
Active
CE MDR
Valid until
28 Nov 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08858251006543TR 00846832089147 | Date24 Aug 2026 | StatusActive |
Certificates
- MDR 730968 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 4 Nov 2025
- Expires
- 28 Nov 2028
- Reason
- Mnf data change
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- TORNIER PERFORM REVERSED GLENOID & REVERSED AUGMENTED GLENOID - CENTRAL SCREW - TI6AL4V-ELI - Class III - NON STERILE
- Model / Reference
- 08858251006543TR, DWJ150
- Primary DI / UDI-DI
- 00846832089147
- Basic UDI-DI
- 08858251006543TR
- EMDN Code
- P09010399 Glenoid components - other
- Device Class
- Class III
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000025261
- Authorised representative
- Stryker European Operations Limited IE-AR-000000092
Other devices from Tornier, Inc.
Properties
Other properties (12)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No