DEVICE: ToggleLoc with Ziploop (00880304470361)
Device Identifier (DI) Information
ToggleLoc with Ziploop
909854
In Commercial Distribution
909854
Biomet Orthopedics, LLC
909854
In Commercial Distribution
909854
Biomet Orthopedics, LLC
No description.
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47138 | Ligament reconstruction instrument set, reusable |
A collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MBI | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
JDR | STAPLE, FIXATION, BONE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K083070 | 000 |
K130033 | 000 |
K973775 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 4.5 MM |
Device Record Status
2cac9d23-eeaf-4f3a-a22b-f03e6b4d4809
May 30, 2025
7
October 24, 2015
May 30, 2025
7
October 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)348-9500
customerservice@zimmerbiomet.com
customerservice@zimmerbiomet.com