DEVICE: Ballista™ Percutaneous (00888480214311)
Device Identifier (DI) Information
Ballista™ Percutaneous
2000-6904
In Commercial Distribution
2000-6904
BIOMET SPINE LLC
2000-6904
In Commercial Distribution
2000-6904
BIOMET SPINE LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
61235 | Cannulated surgical drill bit, single-use |
A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
MNI | Orthosis, spinal pedicle fixation |
KWQ | Appliance, fixation, spinal intervertebral body |
NKB | Thoracolumbosacral pedicle screw system |
MNH | Orthosis, spondylolisthesis spinal fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: BLUNT GUIDEWIRE 1.6MM X 510MM PEDICLE SCREW SYSTEM |
Device Record Status
c7f69f67-b8a7-4da0-8b1f-e71b88e02e28
January 03, 2025
6
June 28, 2020
January 03, 2025
6
June 28, 2020
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)447-3625
USBROCustomerService@zimmerbiomet.com
USBROCustomerService@zimmerbiomet.com