VariAx 58-12009S
GUDID 04546540542434
BONE SCREWS,CROSS-PIN,SELF-T
Stryker Trauma SA
Orthopaedic bone screw, non-bioabsorbable, sterile| Primary Device ID | 04546540542434 |
| NIH Device Record Key | 71926757-6251-40ea-877e-809d52435f79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VariAx |
| Version Model Number | 58-12009S |
| Catalog Number | 58-12009S |
| Company DUNS | 481999654 |
| Company Name | Stryker Trauma SA |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540542434 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062498
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-06-30 |
On-Brand Devices [VariAx]
| 07613327379426 | Bone Screw, T5 |
| 07613327379419 | Bone Screw, T5 |
| 07613327379402 | Bone Screw, T5 |
| 07613327379396 | Bone Screw, T5 |
| 07613327379389 | Bone Screw, T5 |
| 07613327379372 | Bone Screw, T5 |
| 07613327379365 | Bone Screw, T5 |
| 37613327379175 | Bone Screw, T6 |
| 07613327379167 | Locking Screw, T6 |
| 37613327379151 | Locking Screw, T6 |
| 07613327379143 | Bone Screw, T5 |
| 07613327379136 | Bone Screw, T6 |
| 37613327379120 | Bone Screw, T5 |
| 07613327379112 | Bone Screw, T5 |
| 07613327379105 | Locking Screw, T6 |
| 07613327379099 | Bone Screw, T6 |
| 07613327379082 | Bone Screw, T6 |
| 37613327379076 | Locking Screw, T6 |
| 07613327379068 | Bone Screw, T6 |
| 07613327379051 | Bone Screw, T6 |
| 07613327379044 | Locking Screw, T6 |
| 07613327379037 | Bone Screw, T5 |
| 07613327379020 | Locking Screw, T6 |
| 07613327379013 | Locking Screw, T6 |
| 07613327379006 | Locking Screw, T6 |
| 07613327378993 | Bone Screw, T6 |
| 07613327378986 | Bone Screw, T6 |
| 37613327378970 | Locking Screw, T6 |
| 07613327378962 | Locking Screw, T5 |
| 37613327378956 | Bone Screw, T5 |
| 07613327378948 | Bone Screw, T6 |
| 07613327378931 | Emerg. Screw, T6 |
| 07613327378924 | Locking Screw, T5 |
| 07613327378917 | Bone Screw, T6 |
| 07613327378900 | Locking Screw, T5 |
| 07613327378894 | Locking Screw, T5 |
| 07613327378887 | Emerg. Screw, T5 |
| 07613327378870 | Bone Screw, T5 |
| 07613327378863 | Emerg. Screw, T5 |
| 07613327378856 | Locking Screw, T5 |
| 07613327378849 | Locking Screw, T5 |
| 07613327378832 | Locking Screw, T5 |
| 07613327378825 | Bone Screw, T6 |
| 07613327378818 | Bone Screw, T6 |
| 07613327378801 | Locking Screw, T5 |
| 07613327378795 | Washer for 1.7mm Bone Screws |
| 37613327378789 | Locking Screw, T6 |
| 07613327378771 | Emerg. Screw, T6 |
| 07613327378764 | Bone Screw, T5 |
| 37613327378758 | Locking Screw, T6 |
Trademark Results [VariAx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VARIAX 78850093 3202049 Live/Registered |
YAMAHA GUITAR GROUP, INC. 2006-03-30 |
 VARIAX 77936320 3946767 Live/Registered |
Stryker Trauma S.A. 2010-02-16 |
 VARIAX 76423014 2826999 Live/Registered |
YAMAHA GUITAR GROUP, INC. 2002-06-17 |
 VARIAX 74510527 not registered Dead/Abandoned |
Giddings & Lewis, Inc. 1994-04-07 |
 VARIAX 74022306 1640232 Live/Registered |
Sankyo Manufacturing Co., Ltd. 1990-01-25 |
 VARIAX 73477358 not registered Dead/Abandoned |
SANKYO MANUFACTURING CO., LTD. 1984-04-26 |
 VARIAX 72087575 0715073 Live/Registered |
NORDISK VENTILATOR CO. A/S 1959-12-18 |
 VARIAX 72030767 0657107 Live/Registered |
GIDDINGS & LEWIS MACHINE TOOL COMPANY 1957-05-27 |
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