HEDRON
GUDID 00193982125547
HEDRON IC Spacer, 8x14, 6mm, 0°
GLOBUS MEDICAL, INC.
Metallic spinal interbody fusion cage| Primary Device ID | 00193982125547 |
| NIH Device Record Key | 3a23bf51-a2ad-4a77-a5b8-c3b5221971c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEDRON |
| Version Model Number | 1213.4006S |
| Company DUNS | 139105691 |
| Company Name | GLOBUS MEDICAL, 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(610)930-1800 |
| info@globusmedical.com |
Device Dimensions
| Depth | 8 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00193982125547 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191243
FDA Product Code
| ODP | Intervertebral fusion device with bone graft, cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-11-13 |
On-Brand Devices [HEDRON]
| 00193982128616 | HEDRON IC Spacer, 10.5x18, 12mm, 12° |
| 00193982128609 | HEDRON IC Spacer, 10.5x18, 11mm, 12° |
| 00193982128593 | HEDRON IC Spacer, 10.5x18, 10mm, 12° |
| 00193982128586 | HEDRON IC Spacer, 10.5x18, 9mm, 12° |
| 00193982128579 | HEDRON IC Spacer, 10.5x18, 8mm, 12° |
| 00193982128562 | HEDRON IC Spacer, 10.5x18, 7mm, 12° |
| 00193982128555 | HEDRON IC Spacer, 10.5x18, 6mm, 12° |
| 00193982128548 | HEDRON IC Spacer, 10.5x18, 5mm, 12° |
| 00193982128531 | HEDRON IC Spacer, 10.5x18, 12mm, 7° |
| 00193982128524 | HEDRON IC Spacer, 10.5x18, 11mm, 7° |
| 00193982128517 | HEDRON IC Spacer, 10.5x18, 10mm, 7° |
| 00193982128500 | HEDRON IC Spacer, 10.5x18, 9mm, 7° |
| 00193982128494 | HEDRON IC Spacer, 10.5x18, 8mm, 7° |
| 00193982128487 | HEDRON IC Spacer, 10.5x18, 7mm, 7° |
| 00193982128470 | HEDRON IC Spacer, 10.5x18, 6mm, 7° |
| 00193982128463 | HEDRON IC Spacer, 10.5x18, 5mm, 7° |
| 00193982128234 | HEDRON IC Spacer, 10.5x18, 12mm, 0° |
| 00193982128227 | HEDRON IC Spacer, 10.5x18, 11mm, 0° |
| 00193982128210 | HEDRON IC Spacer, 10.5x18, 10mm, 0° |
| 00193982128203 | HEDRON IC Spacer, 10.5x18, 9mm, 0° |
| 00193982128197 | HEDRON IC Spacer, 10.5x18, 8mm, 0° |
| 00193982128180 | HEDRON IC Spacer, 10.5x18, 7mm, 0° |
| 00193982128173 | HEDRON IC Spacer, 10.5x18, 6mm, 0° |
| 00193982128166 | HEDRON IC Spacer, 10.5x18, 5mm, 0° |
| 00193982127336 | HEDRON IC Spacer, 10x16, 12mm, 12° |
| 00193982127329 | HEDRON IC Spacer, 10x16, 11mm, 12° |
| 00193982127312 | HEDRON IC Spacer, 10x16, 10mm, 12° |
| 00193982127305 | HEDRON IC Spacer, 10x16, 9mm, 12° |
| 00193982127299 | HEDRON IC Spacer, 10x16, 8mm, 12° |
| 00193982127282 | HEDRON IC Spacer, 10x16, 7mm, 12° |
| 00193982127275 | HEDRON IC Spacer, 10x16, 6mm, 12° |
| 00193982127268 | HEDRON IC Spacer, 10x16, 5mm, 12° |
| 00193982127251 | HEDRON IC Spacer, 10x16, 12mm, 7° |
| 00193982127244 | HEDRON IC Spacer, 10x16, 11mm, 7° |
| 00193982127237 | HEDRON IC Spacer, 10x16, 10mm, 7° |
| 00193982127220 | HEDRON IC Spacer, 10x16, 9mm, 7° |
| 00193982127213 | HEDRON IC Spacer, 10x16, 8mm, 7° |
| 00193982127206 | HEDRON IC Spacer, 10x16, 7mm, 7° |
| 00193982127190 | HEDRON IC Spacer, 10x16, 6mm, 7° |
| 00193982127183 | HEDRON IC Spacer, 10x16, 5mm, 7° |
| 00193982126957 | HEDRON IC Spacer, 10x16, 12mm, 0° |
| 00193982126940 | HEDRON IC Spacer, 10x16, 11mm, 0° |
| 00193982126933 | HEDRON IC Spacer, 10x16, 10mm, 0° |
| 00193982126926 | HEDRON IC Spacer, 10x16, 9mm, 0° |
| 00193982126919 | HEDRON IC Spacer, 10x16, 8mm, 0° |
| 00193982126902 | HEDRON IC Spacer, 10x16, 7mm, 0° |
| 00193982126896 | HEDRON IC Spacer, 10x16, 6mm, 0° |
| 00193982126889 | HEDRON IC Spacer, 10x16, 5mm, 0° |
| 00193982126018 | HEDRON IC Spacer, 8x14, 12mm, 12° |
| 00193982126001 | HEDRON IC Spacer, 8x14, 11mm, 12° |
Trademark Results [HEDRON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEDRON 97236674 not registered Live/Pending |
Halliburton Energy Services, Inc. 2022-01-25 |
 HEDRON 88895758 not registered Live/Pending |
Tilevera LLC 2020-04-30 |
 HEDRON 88450490 not registered Live/Pending |
Globus Medical Inc. 2019-05-29 |
 HEDRON 87776132 not registered Live/Pending |
Globus Medical, Inc. 2018-01-30 |
 HEDRON 87588326 not registered Live/Pending |
Worn and Wound LLC 2017-08-29 |
 HEDRON 77476817 not registered Dead/Abandoned |
Empire of Sports Developments Ltd. 2008-05-16 |
 HEDRON 74547546 1916459 Live/Registered |
VITRABLOK, S.R.O. 1994-07-08 |
 HEDRON 74424249 1879572 Dead/Cancelled |
Domarkas, Andrew 1993-08-12 |
 HEDRON 73514877 1389093 Dead/Cancelled |
PITTSBURGH CORNING CORPORATION 1984-12-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.