Pinnacle Porocoat 1217-22-058
by Depuy Orthopaedics, Inc. EUDAMEDGUDID
Active
Ref 1217-22-058Model PINNACLE Acetabular Shells - POROCOAT Coated
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | NumberMDR 776549 | Date30 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10603295009856 | Date24 Mar 2015 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
- MDR 776549 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 30 Jun 2026
- Expires
- 4 Jun 2029
- Reason
- Change approved
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- Pinnacle EUDAMEDPinnacle Porocoat GUDID
- Generic Name
- Acetabular shell
- Device Name
- Acetabular Shells - POROCOAT Coated
- Model / Ref / Catalog
- 1217-22-058, PINNACLE Acetabular Shells - POROCOAT Coated, 121722058
- Primary DI / UDI-DI
- 10603295009856
- Basic UDI-DI
- 0603295a002708M
- FDA Product Code
- MRA, LPH
- EMDN Code
- P090803010201,P0908030302
- GMDN Term
- Acetabular shell
- Device Class
- Class III
- Regulation Number
- 888.3358
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Conditional
Other devices from Depuy Orthopaedics, Inc.
Properties
Other properties (18)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No