CoverLoc™ Volar Plate
GUDID 00846832001361
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 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 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 | 00846832001361 |
| NIH Device Record Key | 9979fff0-7a53-42c6-8d1b-1c6aa0dee355 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoverLoc™ Volar Plate |
| Version Model Number | 0013318 |
| 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 Dimensions
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.3 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832001361 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052150
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
Moist Heat or Steam Sterilization
[00846832001361]
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 | 2015-09-25 |
On-Brand Devices [CoverLoc™ Volar Plate]
| 00846832001620 | 0014824 |
| 00846832001613 | 0014822 |
| 00846832001606 | 0014820 |
| 00846832001590 | 0014818 |
| 00846832001583 | 0014816 |
| 00846832001569 | 0014326 |
| 00846832001552 | 0014324 |
| 00846832001545 | 0014322 |
| 00846832001538 | 0014320 |
| 00846832001521 | 0014318 |
| 00846832001514 | 0014316 |
| 00846832001507 | 0014314 |
| 00846832001453 | 0014126 |
| 00846832001446 | 0014124 |
| 00846832001439 | 0014122 |
| 00846832001422 | 0014120 |
| 00846832001415 | 0014118 |
| 00846832001408 | 0014116 |
| 00846832001392 | 0014114 |
| 00846832001385 | 0014112 |
| 00846832001378 | 0014110 |
| 00846832001361 | 0013318 |
| 00846832001354 | 0013316 |
| 00846832001347 | 0013314 |
| 00846832001330 | 0013312 |
| 00846832001323 | 0013310 |
| 00846832001316 | 0013308 |
| 00846832001248 | 0011222 |
| 00846832001231 | 0011221 |
| 00846832001224 | 0011220 |
| 00846832001217 | 0011219 |
| 00846832001200 | 0011218 |
| 00846832001194 | 0011217 |
| 00846832001187 | 0011216 |
| 00846832001170 | 0011215 |
| 00846832001163 | 0011212 |
| 00846832001156 | 0011211 |
| 00846832001149 | 0011210 |
| 00846832001132 | 0011208 |
| 00846832001125 | 0011206 |
| 00846832001118 | 0011205 |
| 00846832001101 | 0011204 |
| 00846832001095 | 0011203 |
| 00846832001088 | 0011202 |
| 00846832001071 | 0011201 |
Trademark Results [CoverLoc]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COVERLOC 77120473 3347170 Dead/Cancelled |
DVO ACQUISITION, INC. 2007-03-02 |
 COVERLOC 75715416 2443376 Dead/Cancelled |
Ayele, Fikre S. 1999-06-22 |
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