Spikes C-SPIKE-10
GUDID 00810017910113
Saber-C Spikes, 10mm
ELEVATION SPINE, INC.
Intervertebral-body internal spinal fixation system| Primary Device ID | 00810017910113 |
| NIH Device Record Key | c34521b0-6fb5-4a3f-ae89-b36115f94801 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spikes |
| Version Model Number | C-SPIKE-10 |
| Catalog Number | C-SPIKE-10 |
| Company DUNS | 085718404 |
| Company Name | ELEVATION SPINE, 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810017910113 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190885
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-13 |
| Device Publish Date | 2019-12-05 |
On-Brand Devices [Spikes]
| 00810017910113 | Saber-C Spikes, 10mm |
| 00810017910106 | Saber-C Spikes, 9mm |
| 00810017910090 | Saber-C Spikes, 8mm |
| 00810017910083 | Saber-C Spikes, 7mm |
| 00810017910076 | Saber-C Spikes, 5-6mm |
Trademark Results [Spikes]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIKES 88152709 5777723 Live/Registered |
T3I Pty Ltd 2018-10-12 |
 SPIKES 87872111 not registered Live/Pending |
T3I Pty Ltd 2018-04-11 |
 SPIKES 87672458 not registered Dead/Abandoned |
ESR PERFORMANCE CORP. 2017-11-05 |
 SPIKES 87395793 not registered Dead/Abandoned |
Spikes Beverage Co, LLC 2017-04-03 |
 SPIKES 87337490 not registered Dead/Abandoned |
guessas pascal h 2017-02-15 |
 SPIKES 85980588 4562634 Live/Registered |
Spikes, Inc. 2013-03-12 |
 SPIKES 85940748 4550382 Live/Registered |
Russell, Richard 2013-05-23 |
 SPIKES 85874372 4685292 Live/Registered |
CYBERINC CORPORATION 2013-03-12 |
 SPIKES 85135408 4044041 Live/Registered |
LiDestri Foods, Inc. 2010-09-22 |
 SPIKES 78351313 3007329 Live/Registered |
Rochester Community Baseball 2004-01-13 |
 SPIKES 74679905 not registered Dead/Abandoned |
BIRD-X, INC. 1995-05-25 |
 SPIKES 73740500 1556915 Dead/Cancelled |
CLARKE, ROBERT F. 1988-07-18 |
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