Primary Device ID | 00846468085513 |
NIH Device Record Key | c8ea59c2-f13b-4d2a-8761-c2810e2bb572 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fortilink-L IBF System with TETRAfuse 3D Technology |
Version Model Number | 65-L-1845-13-6L |
Catalog Number | 65-L-1845-13-6L |
Company DUNS | 793384496 |
Company Name | Pioneer Surgical Technology, 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 | true |
OTC Over-The-Counter | false |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 00191083007212 [Primary] |
GS1 | 00846468085513 [Primary] |
MAX | Intervertebral fusion device with bone graft, lumbar |
ODP | Intervertebral fusion device with bone graft, cervical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2017-10-30 |
00846468086633 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 60mm (L |
00846468086626 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 60mm (L |
00846468086619 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 60mm (L |
00846468086602 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 55mm (L |
00846468086596 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 55mm (L |
00846468086589 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 55mm (L |
00846468086572 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 50mm (L |
00846468086565 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 50mm (L |
00846468086558 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 50mm (L |
00846468086541 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 45mm (L |
00846468086534 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 45mm (L |
00846468086527 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 45mm (L |
00846468086442 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 40mm (L |
00846468086435 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 40mm (L |
00846468086428 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 40mm (L |
00846468086411 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 40mm (L |
00846468086404 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 60mm (L |
00846468086398 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 60mm (L |
00846468086381 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 55mm (L |
00846468086374 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 55mm (L |
00846468086367 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 50mm (L |
00846468086350 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 50mm (L |
00846468086343 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 45mm (L |
00846468086336 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 45mm (L |
00846468086329 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 60mm (L |
00846468086312 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 60mm (L |
00846468086305 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 60mm (L |
00846468086299 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 55mm (L |
00846468086282 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 55mm (L |
00846468086275 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 55mm (L |
00846468086268 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 50mm (L |
00846468086251 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 50mm (L |
00846468086244 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 50mm (L |
00846468086237 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 45mm (L |
00846468086220 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 45mm (L |
00846468086213 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 22mm (W), 45mm (L |
00846468086206 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 60mm (L |
00846468086190 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 60mm (L |
00846468086183 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 60mm (L |
00846468086176 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 60mm (L |
00846468086169 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 55mm (L |
00846468086152 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 55mm (L |
00846468086145 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 55mm (L |
00846468086138 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 55mm (L |
00846468086121 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 50mm (L |
00846468086114 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 50mm (L |
00846468086107 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 50mm (L |
00846468086091 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 50mm (L |
00846468086084 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 45mm (L |
00846468086077 | Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 26mm (W), 45mm (L |