MaxLock Extreme™

GUDID 00846832028368

TORNIER, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Primary Device ID	00846832028368
NIH Device Record Key	602fec60-836b-4c64-9213-62fddf3e294a
Commercial Distribution Status	In Commercial Distribution
Brand Name	MaxLock Extreme™
Version Model Number	CLA-002-SUP6
Company DUNS	968990812
Company Name	TORNIER, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com
Phone	+1(888)494-7950
Email	customerservice@tornier.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832028368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090289

FDA Product Code

HRS	PLATE, FIXATION, BONE