CalcLock™
GUDID 00846832027729
TORNIER, INC.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 00846832027729 |
| NIH Device Record Key | b7e370ea-9ea0-4113-ab4d-5f5111bd9a63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CalcLock™ |
| Version Model Number | CAT-011-40-22 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832027729 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061400
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
Moist Heat or Steam Sterilization
[00846832027729]
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™]
Trademark Results [CalcLock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALCLOCK 78967900 3386979 Live/Registered |
ORTHOHELIX SURGICAL DESIGNS, INC. 2006-09-06 |
 CALCLOCK 73151029 1097316 Dead/Cancelled |
Timex Corporation 1977-12-05 |
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