TOWNLEY™ Transfacetpedicular Screw Fixation System
GUDID 00613994799593
SCREW X0410173 CORT NON-CANN TI 3.5X18
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00613994799593 |
| NIH Device Record Key | 409b3b30-452f-42f2-9917-74fcf47e866e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TOWNLEY™ Transfacetpedicular Screw Fixation System |
| Version Model Number | X0410173 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 3.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994799593 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K021705
FDA Product Code
| MRW | SYSTEM, FACET SCREW SPINAL DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
Moist Heat or Steam Sterilization
[00613994799593]
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 | 2015-09-01 |
On-Brand Devices [TOWNLEY™ Transfacetpedicular Screw Fixation System]
| 00613994799623 | SCREW X0410304 CORT NON-CANN TI 4.0X24 |
| 00613994799616 | SCREW X0410303 CORT NON-CANN TI 4.0X22 |
| 00613994799609 | SCREW X0410302 CORT NON-CANN TI 4.0X20 |
| 00613994799593 | SCREW X0410173 CORT NON-CANN TI 3.5X18 |
| 00613994799586 | SCREW X0410172 CORT NON-CANN TI 3.5X16 |
| 00613994799579 | SCREW X0410171 CORT NON-CANN TI 3.5X14 |
| 00613994799562 | SCREW X0410170 CORT NON-CANN TI 3.5X12 |
| 00613994799555 | SCREW X0410169 CORT NON-CANN TI 3.5X10 |
| 00613994723277 | SCREW X0509524 CORTICAL TI 3.5X28 |
| 00613994723260 | SCREW X0509523 CORTICAL TI 3.5X26 |
| 00613994723253 | SCREW X0509522 CORTICAL TI 3.5X24 |
| 00613994723246 | SCREW X0509521 CORTICAL TI 3.5X22 |
| 00613994723239 | SCREW X0509520 CORTICAL TI 3.5X20 |
| 00613994723222 | SCREW X0509519 CORTICAL TI 3.5X18 |
| 00613994723215 | SCREW X0509518 CORTICAL TI 3.5X16 |
| 00613994723208 | SCREW X0509517 CORTICAL TI 3.5X14 |
| 00681490860574 | UCS 4.0X32 CANN LAG SCR TI |
| 00681490860567 | UCS 4.0X30 X873-130 CANN LAG SCR TI |
| 00681490860550 | UCS 4.0X28 CANN LAG SCR TI |
| 00681490860543 | UCS 4.0X26 CANN LAG SCR TI |
| 00681490860536 | UCS 4.0X24 CANN LAG SCR TI |
| 00681490833240 | UCS 4.0X34 CANN LAG SCR TI |
| 00721902298493 | UCS 4.0X28 CANN SCR TI |
| 00721902298479 | UCS 4.0X26 CANN SCR TI |
| 00721902298462 | UCS 4.0X24 CANN SCR TI |
| 00721902298455 | UCS 4.0X22 CANN SCR TI |
| 00721902298448 | UCS 4.0X20 CANN SCR TI |
| 00721902298431 | UCS 4.0X18 CANN SCR TI |
| 00721902043819 | UCS 4.0X22 CANN LAG SCR TI |
| 00721902043802 | UCS 4.0X20 CANN LAG SCR TI |
| 00721902043796 | UCS 4.0X18 CANN LAG SCR TI |
Trademark Results [TOWNLEY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOWNLEY 86511853 4858046 Live/Registered |
Shane Townley Arts Foundation INC 2015-01-23 |
 TOWNLEY 77375008 3562775 Live/Registered |
Townley Wines LLC 2008-01-18 |
 TOWNLEY 76357510 not registered Dead/Abandoned |
Merillat Industries, Inc. 2002-01-11 |
 TOWNLEY 75348128 2263812 Dead/Cancelled |
FINOVA CAPITAL CORPORATION 1997-08-27 |
 TOWNLEY 74058015 1637964 Dead/Cancelled |
Townley Research and Consulting, Inc. 1990-05-11 |
 TOWNLEY 73597330 1429689 Dead/Cancelled |
TOWNLEY RESEARCH AND CONSULTING, INC. 1986-05-07 |
 TOWNLEY 72152407 0756905 Dead/Expired |
IMPERIAL WALLPAPER MILL, INC. 1962-09-04 |
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