Primary Device ID | 00810017913190 |
NIH Device Record Key | 7e2c2766-88db-42b1-be78-dc9174b11a85 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Trial Head 15x18x8 9 deg. |
Version Model Number | CI-TH5898 |
Catalog Number | CI-TH5898 |
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 |
Phone | 844-415-0226 |
info@elevationspine.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810017913190 [Primary] |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-01-16 |
Device Publish Date | 2020-01-08 |
00810017913411 - SABER-C RASP | 2024-01-29 Saber-C Rasp, 12x15x5, 6 deg. |
00810017913428 - SABER-C RASP | 2024-01-29 Saber-C Rasp, 14x17x5, 6 deg |
00810017913497 - SABER-C BASE WITH INSERT TRAY | 2024-01-29 SABER-C BASE WITH INSERT TRAY |
00810017913435 - Carriage 5-6mm | 2024-01-26 Carriage 5-6mm |
00810017913442 - Carriage 7mm | 2024-01-26 Carriage 7mm |
00810017913459 - Carriage 8mm | 2024-01-26 Carriage 8mm |
00810017913466 - Carriage 9mm | 2024-01-26 Carriage 9mm |
00810017913473 - Carriage 10mm | 2024-01-26 Carriage 10mm |