TENOR® SPINAL SYSTEM
GUDID 00673978037066
CROSSLINK 806LT55L100T TRNSVR W 100MM BA
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00673978037066 |
| NIH Device Record Key | a58b305e-ae70-4c19-9cfd-18bb62c698b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TENOR® SPINAL SYSTEM |
| Version Model Number | 806LT55L100T |
| 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
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
| Length | 100 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00673978037066 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K991528
FDA Product Code
| MNH | Orthosis, spondylolisthesis spinal fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
Moist Heat or Steam Sterilization
[00673978037066]
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 | 2015-08-23 |
On-Brand Devices [TENOR® SPINAL SYSTEM]
| 00681490881753 | ROD 806TS55L170T TNR 1.2 D5.5X170MM |
| 00681490881746 | ROD 806TS55L130T TNR 1.2 5.5X130MM |
| 00673978971070 | SCREW 806VA55T SET FOR CLSD CLAMP |
| 00673978971063 | ROD 806TS55L230T TNR 1.2 5.5 X230MM |
| 00673978971056 | ROD 806TS55L210T TNR 1.2 D5.5MM |
| 00673978971049 | ROD 806TS55L190T TNR 1.2 5.5X190MM |
| 00673978971032 | ROD 806TS55L150T TNR 1.2 5.5X150MM |
| 00673978037288 | ROD 806TS55L90T TNR 1.2 D 5.5X90MM |
| 00673978037271 | ROD 806TS55L80T TNR 5.5X80MM |
| 00673978037264 | ROD 806TS55L70T TNR 1.2 5.5X70MM |
| 00673978037257 | ROD 806TS55L60T TNR 5.5X60MM |
| 00673978037240 | ROD 806TS55L50T TNR 1.2 5.5X50MM |
| 00673978037233 | ROD 806TS55L40T TNR 5.5X40MM |
| 00673978037226 | ROD 806TS55L240T TNR 1.2 D5.5 L240MM |
| 00673978037219 | ROD 806TS55L220T TNR 1.2 D5.5 L220MM |
| 00673978037202 | ROD 806TS55L200T TNR 1.2 D5.5 L200MM |
| 00673978037196 | ROD 806TS55L180T TNR MOD GDLH 5.5X180 |
| 00673978037189 | ROD 806TS55L160T TNR MOD GDLH 5.5X160 |
| 00673978037172 | ROD 806TS55L140T TNR MOD GDLH 5.5X140 |
| 00673978037165 | ROD 806TS55L120T TNR MOD GDLH 5.5X120 |
| 00673978037158 | ROD 806TS55L110T TNR 5.5X110MM |
| 00673978037141 | ROD 806TS55L100T TNR 5.5X100MM |
| 00673978037134 | CLAMP 806PS55T CLAMPS FOR 5.5MM ROD |
| 00673978037127 | CLAMP 806PR55T OFFSET CLAMP |
| 00673978037110 | CONNECTOR 806PC55T CLOSED |
| 00673978037103 | CLAMP 806PA55T MONOBLOC |
| 00673978037097 | CROSSLINK 806LT55L80T TRNSVR W 80MM BAR |
| 00673978037080 | CROSSLINK 806LT55L60T TRNSVR W 60MM BAR |
| 00673978037073 | CROSSLINK 806LT55L40T TRNSVR W 40MM BAR |
| 00673978037066 | CROSSLINK 806LT55L100T TRNSVR W 100MM BA |
| 00673978037059 | NUT 806ECT SELF BREAKING |
Trademark Results [TENOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENOR 98741238 not registered Live/Pending |
Tenor Engineering Group Limited Liability Company 2024-09-09 |
 TENOR 97795688 not registered Live/Pending |
Amazon Technologies, Inc. 2023-02-15 |
 TENOR 97670019 not registered Live/Pending |
Tenor Capital Management Company, L.P. 2022-11-09 |
 TENOR 97670008 not registered Live/Pending |
Tenor Capital Management Company, L.P. 2022-11-09 |
 TENOR 90830169 not registered Live/Pending |
Steelcase Inc. 2021-07-15 |
 TENOR 88735590 not registered Live/Pending |
Robern, Inc. 2019-12-20 |
 TENOR 87846488 not registered Live/Pending |
Brandster GmbH 2018-03-23 |
 TENOR 87684444 not registered Live/Pending |
Buy Surprise LLC 2017-11-14 |
 TENOR 87350159 not registered Dead/Abandoned |
CKL Holdings N.V. 2017-02-26 |
 TENOR 87289726 5434365 Live/Registered |
Oneida Ltd. 2017-01-04 |
 TENOR 87132870 5133882 Live/Registered |
GOOGLE LLC 2016-08-09 |
 TENOR 87132848 5141878 Live/Registered |
GOOGLE LLC 2016-08-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.