HIP Instruments 01.18.10.415
Ref 01.18.10.415
HIP Instruments 01.18.10.415 is a Class I device made by Medacta International, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-07630040745536) and listed in FDA GUDID since 9 Dec 2020 (UDI-DI 07630040745536), active as of 7 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-07630040745536 07630040745536 | Date30 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07630040745536 | Date9 Dec 2020 | StatusListed |
Official records
- EUDAMED public site B-07630040745536
- AccessGUDID record 07630040745536
Across registries
- EUDAMED Basic UDI-DI B-07630040745536 registered 30 Oct 2026 Active
- FDA GUDID UDI-DI 07630040745536 listed 9 Dec 2020 Listed
Timeline
- Listed FDA GUDID 07630040745536
- Registered EUDAMED B-07630040745536
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- AMIStem Broach v2 #5 EUDAMEDHIP Instruments GUDID
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device name
- Hip Broach / Femoral Rasp / Puncher
- Model / reference
- 01.18.10.415
- Primary DI / UDI-DI
- 07630040745536
- Basic UDI-DI
- B-07630040745536
- 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
Similar devices in this category
Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.
- USTAR II Knee System 2915-2110 by United Orthopedic Corporation
- Instrument Box CS100501 by Tianjin Zhengtian Medical Instrument Co., Ltd.
- U2 Total Knee System 2603-6051 by UNITED ORTHOPEDIC CORP.
- U2 Total Knee System 2303-2469-RK by UNITED ORTHOPEDIC CORP.
- DCI™ CBT16186 by Paradigm Spine GmbH
- NexGen® 5989-07-10 00-5989-007-10 by Zimmer, Inc.
- Persona® 42-5399-052-85 by Zimmer, Inc.
- OSS™ 110018802 by Biomet Orthopedics, Inc.
- SMR Shoulder Stopper 9013.75.751 by Limacorporate
- AESCULAP NE331R by AESCULAP, INC.