CalcLock™

GUDID 00846832027873

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: 00846832027873
• NIH Device Record Key: 9049773a-267a-4563-916b-911c13938ce0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CalcLock™
• Version Model Number: CAT-011-40P-45
• 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	00846832027873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061400

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

[00846832027873]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-16

On-Brand Devices [CalcLock™]

• 00846832027996: CAT-021-35-40
• 00846832027989: CAT-021-35-375
• 00846832027972: CAT-021-35-35
• 00846832027965: CAT-021-35-325
• 00846832027958: CAT-021-35-30
• 00846832027941: CAT-021-35-28
• 00846832027934: CAT-021-35-26
• 00846832027927: CAT-021-35-24
• 00846832027910: CAT-021-35-22
• 00846832027903: CAT-021-35-20
• 00846832027897: CAT-011-40P-50
• 00846832027880: CAT-011-40P-475
• 00846832027873: CAT-011-40P-45
• 00846832027866: CAT-011-40P-425
• 00846832027859: CAT-011-40P-40
• 00846832027842: CAT-011-40P-375
• 00846832027835: CAT-011-40P-35
• 00846832027828: CAT-011-40P-325
• 00846832027811: CAT-011-40P-30
• 00846832027804: CAT-011-40-40
• 00846832027798: CAT-011-40-375
• 00846832027781: CAT-011-40-35
• 00846832027774: CAT-011-40-325
• 00846832027767: CAT-011-40-30
• 00846832027750: CAT-011-40-28
• 00846832027743: CAT-011-40-26
• 00846832027736: CAT-011-40-24
• 00846832027729: CAT-011-40-22
• 00846832027712: CAT-011-40-20
• 00846832027705: CAT-011-35-60
• 00846832027699: CAT-011-35-55
• 00846832027682: CAT-011-35-50
• 00846832027675: CAT-011-35-475
• 00846832027668: CAT-011-35-45
• 00846832027651: CAT-011-35-425
• 00846832027644: CAT-011-35-40
• 00846832027637: CAT-011-35-375
• 00846832027620: CAT-011-35-35
• 00846832027613: CAT-011-35-325
• 00846832027606: CAT-011-35-30
• 00846832027590: CAT-011-35-28
• 00846832027583: CAT-011-35-26
• 00846832027576: CAT-011-35-24
• 00846832027569: CAT-011-35-22
• 00846832027552: CAT-011-35-20
• 00846832027484: CAT-001-XLR
• 00846832027477: CAT-001-XLL
• 00846832027460: CAT-001-SR
• 00846832027453: CAT-001-SL
• 00846832027446: CAT-001-LR