JuggerLoc™ 110017271
Ref 110017271
Active
CE MDD
Valid until
Not listed
FDA recalls
None ongoingDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00880304857315 00880304857315 | Date19 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00880304857315 | Date28 Jul 2017 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
-
- Terminated Z-0809-2022
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
-
- Terminated Z-1363-2015
The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- JuggerLoc™
- Generic Name
- Orthopaedic bone wire
- Device Name
- SM JLoc 2_9 Fluted Suture Passer Wire
- Model / Ref / Catalog
- 110017271
- Primary DI / UDI-DI
- 00880304857315
- Basic UDI-DI
- B-00880304857315
- 510(k) Number
- FDA Product Code
- JDR, MBI
- EMDN Code
- L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
- GMDN Term
- Orthopaedic bone wire
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 888.3030, 888.3040
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (19)
- Implantable: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No