Mallet CI-MALLET
GUDID 00810017912346
Mallet
ELEVATION SPINE, INC.
Intervertebral-body internal spinal fixation system| Primary Device ID | 00810017912346 |
| NIH Device Record Key | 598fa8c3-eb53-4ed3-898f-d63cf6173077 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mallet |
| Version Model Number | CI-MALLET |
| Catalog Number | CI-MALLET |
| 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 | 00810017912346 [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 | 2020-01-07 |
| Device Publish Date | 2019-12-30 |
Devices Manufactured by ELEVATION SPINE, INC.
| 00810017915262 - Screw Handle | 2025-09-22 Screw Handle (Ratcheting) |
| 00810017915279 - Spike Implants | 2025-09-22 Saber-C 14mm Spikes (No Carriage) |
| 00810017914777 - Double Ended Rasp/Trial 12x15x5, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x5, 6° |
| 00810017914784 - Double Ended Rasp/Trial 12x15x6, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x6, 6° |
| 00810017914791 - Double Ended Rasp/Trial 12x15x7, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x7, 6° |
| 00810017914807 - Double Ended Rasp/Trial 12x15x8, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x8, 6° |
| 00810017914814 - Double Ended Rasp/Trial 12x15x9, 6° | 2025-04-07 Double Ended Rasp/Trial 12x15x9, 6° |
| 00810017914821 - Double Ended Rasp/Trial 14x17x5, 6° | 2025-04-07 Double Ended Rasp/Trial 14x17x5, 6° |
Trademark Results [Mallet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MALLET 98385272 not registered Live/Pending |
DEAN, JODY S 2024-01-31 |
 MALLET 98214841 not registered Live/Pending |
Mallet 3D LLC 2023-10-09 |
 MALLET 98138265 not registered Live/Pending |
Vantage Specialty Chemicals, Inc. 2023-08-17 |
 MALLET 97179677 not registered Live/Pending |
Croquet Brands, Inc. 2021-12-19 |
 MALLET 87021642 5154429 Live/Registered |
IMPLUS FOOTCARE, LLC 2016-05-02 |
 MALLET 78557072 3262299 Live/Registered |
NuFarm Americas, Inc. 2005-01-31 |
 MALLET 78394347 2935218 Live/Registered |
Crank Brothers, Inc. 2004-03-31 |
 MALLET 73297087 1240418 Dead/Cancelled |
Bowen Tiesmiths, Ltd. 1981-02-13 |
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