HIP Instruments 01.18.10.313
Ref 01.18.10.313
HIP Instruments 01.18.10.313 is a Class I device made by Medacta International SA, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-07630971282483) and listed in FDA GUDID since 10 Feb 2021 (UDI-DI 07630971282483), active as of 12 Nov 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-07630971282483 07630971282483 | Date30 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07630971282483 | Date10 Feb 2021 | StatusListed |
Official records
- EUDAMED public site B-07630971282483
- AccessGUDID record 07630971282483
Across registries
- EUDAMED Basic UDI-DI B-07630971282483 registered 30 Oct 2026 Active
- FDA GUDID UDI-DI 07630971282483 listed 10 Feb 2021 Listed
Timeline
- Listed FDA GUDID 07630971282483
- Registered EUDAMED B-07630971282483
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- AMIStem Distal Broach size 3D EUDAMEDHIP Instruments GUDID
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device name
- Hip Broach / Femoral Rasp / Puncher
- Model / reference
- 01.18.10.313
- Primary DI / UDI-DI
- 07630971282483
- Basic UDI-DI
- B-07630971282483
- FDA product code
- LXH
- EMDN code
- L091199 Orthopaedic prosthetics instruments, reusable - other
- GMDN term
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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