DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM
GUDID 00643169361263
MODULE 7742008 DIVERG NO-P PARALLEL
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray| Primary Device ID | 00643169361263 |
| NIH Device Record Key | 7d536846-00c6-46c0-a5d4-77ef4a9b1ac3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM |
| Version Model Number | 7742008 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169361263 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190840
FDA Product Code
| FSM | TRAY, SURGICAL, INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
[00643169361263]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2017-12-29 |
On-Brand Devices [DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM]
| 00643169516397 | TRIAL 77362612 DIVERGE 6 DEG 11-12X20X16 |
| 00643169516380 | TRIAL 77362412 DIVERGE 6 DEG 11-12X20X14 |
| 00643169516373 | TRIAL 77367612 DIVERGE 6 DEG 11-12X17X16 |
| 00643169516366 | TRIAL 77367412 DIVERGE 6 DEG 11-12X17X14 |
| 00643169516359 | TRIAL 77365412 DIVERGE 6 DEG 11-12X15X14 |
| 00643169516342 | TRIAL 77365212 DIVERGE 6 DEG 11-12X15X12 |
| 00643169516335 | TRIAL 77362690 DIVERGE 6 DEG 9-10X20X16 |
| 00643169516328 | TRIAL 77362490 DIVERGE 6 DEG 9-10X20X14 |
| 00643169516311 | TRIAL 77367690 DIVERGE 6 DEG 9-10X17X16 |
| 00643169516304 | TRIAL 77367490 DIVERGE 6 DEG 9-10X17X14 |
| 00643169516298 | TRIAL 77365490 DIVERGE 6 DEG 9-10X15X14 |
| 00643169516281 | TRIAL 77365290 DIVERGE 6 DEG 9-10X15X12 |
| 00643169516274 | TRIAL 77362678 DIVERGE 6 DEG 7-8X20X16 |
| 00643169516267 | TRIAL 77362478 DIVERGE 6 DEG 7-8X20X14 |
| 00643169516250 | TRIAL 77367678 DIVERGE 6 DEG 7-8X17X16 |
| 00643169516243 | TRIAL 77367478 DIVERGE 6 DEG 7-8X17X14 |
| 00643169516236 | TRIAL 77365478 DIVERGE 6 DEG 7-8X15X14 |
| 00643169516229 | TRIAL 77365278 DIVERGE 6 DEG 7-8X15X12 |
| 00643169516212 | TRIAL 77362656 DIVERGE 6 DEG 5-6X20X16 |
| 00643169516205 | TRIAL 77362456 DIVERGE 6 DEG 5-6X20X14 |
| 00643169516199 | TRIAL 77367656 DIVERGE 6 DEG 5-6X17X16 |
| 00643169516182 | TRIAL 77367456 DIVERGE 6 DEG 5-6X17X14 |
| 00643169516175 | TRIAL 77365456 DIVERGE 6 DEG 5-6X15X14 |
| 00643169516168 | TRIAL 77365256 DIVERGE 6 DEG 5-6X15X12 |
| 00643169516151 | TRIAL 77302612 DIVERGE 0 DEG 11-12X20X16 |
| 00643169516144 | TRIAL 77302412 DIVERGE 0 DEG 11-12X20X14 |
| 00643169516137 | TRIAL 77307612 DIVERGE 0 DEG 11-12X17X16 |
| 00643169516120 | TRIAL 77307412 DIVERGE 0 DEG 11-12X17X14 |
| 00643169516113 | TRIAL 77305412 DIVERGE 0 DEG 11-12X15X14 |
| 00643169516106 | TRIAL 77305212 DIVERGE 0 DEG 11-12X15X12 |
| 00643169516090 | TRIAL 77302690 DIVERGE 0 DEG 9-10X20X16 |
| 00643169516083 | TRIAL 77302490 DIVERGE 0 DEG 9-10X20X14 |
| 00643169516076 | TRIAL 77307690 DIVERGE 0 DEG 9-10X17X16 |
| 00643169516069 | TRIAL 77307490 DIVERGE 0 DEG 9-10X17X14 |
| 00643169516052 | TRIAL 77305490 DIVERGE 0 DEG 9-10X15X14 |
| 00643169516045 | TRIAL 77305290 DIVERGE 0 DEG 9-10X15X12 |
| 00643169516038 | TRIAL 77302678 DIVERGE 0 DEG 7-8X20X16 |
| 00643169516021 | TRIAL 77302478 DIVERGE 0 DEG 7-8X20X14 |
| 00643169516014 | TRIAL 77307678 DIVERGE 0 DEG 7-8X17X16 |
| 00643169516007 | TRIAL 77307478 DIVERGE 0 DEG 7-8X17X14 |
| 00643169515994 | TRIAL 77305478 DIVERGE 0 DEG 7-8X15X14 |
| 00643169515987 | TRIAL 77305278 DIVERGE 0 DEG 7-8X15X12 |
| 00643169515970 | TRIAL 77302656 DIVERGE 0 DEG 5-6X20X16 |
| 00643169515963 | TRIAL 77302456 DIVERGE 0 DEG 5-6X20X14 |
| 00643169515956 | TRIAL 77307656 DIVERGE 0 DEG 5-6X17X16 |
| 00643169515949 | TRIAL 77307456 DIVERGE 0 DEG 5-6X17X14 |
| 00643169515932 | TRIAL 77305456 DIVERGE 0 DEG 5-6X15X14 |
| 00643169515925 | TRIAL 77305256 DIVERGE 0 DEG 5-6X15X12 |
| 00643169362895 | INSERTER 6620810 FREEHND INSRTER SLEEVE |
| 00643169362888 | GUIDE 7730812 MINI-PLATE 12MM GUIDE |
Trademark Results [DIVERGENCE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIVERGENCE 98062878 not registered Live/Pending |
Mid America Pet Food, LLC 2023-06-28 |
 DIVERGENCE 88866198 not registered Live/Pending |
Loveland Products, Inc. 2020-04-09 |
 DIVERGENCE 88751831 not registered Live/Pending |
NL Enterprises, LLC 2020-01-08 |
 DIVERGENCE 88024730 not registered Dead/Abandoned |
Marlabs.inc 2018-07-03 |
 DIVERGENCE 87954231 5904263 Live/Registered |
Alexander Marine USA Inc. 2018-06-08 |
 DIVERGENCE 85369051 4679213 Live/Registered |
Warsaw Orthopedic, Inc. 2011-07-12 |
 DIVERGENCE 79285718 not registered Live/Pending |
THE SPIRITS WORKSHOP LIMITED 2020-04-14 |
 DIVERGENCE 78976617 3059656 Dead/Cancelled |
DIVERGENCE, INC. 2001-06-21 |
 DIVERGENCE 78873601 3826516 Dead/Cancelled |
Divergence, Inc. 2006-05-01 |
 DIVERGENCE 78112801 not registered Dead/Abandoned |
DIVERGENCE, INC. 2002-03-05 |
 DIVERGENCE 78070259 3308002 Dead/Cancelled |
DIVERGENCE, INC. 2001-06-21 |
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