Primary Device ID | B70712823000005A0 |
NIH Device Record Key | ccd2e33b-148d-4cd7-855e-6cfff166e32a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KIT DUALX PLIF 8 DEG x 9-12MM |
Version Model Number | 12823000005A |
Company DUNS | 081021000 |
Company Name | AMPLIFY SURGICAL, 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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 949-220-1286 |
admin@innovasiveinc.com | |
Phone | 949-220-1286 |
admin@innovasiveinc.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B70712823000005A0 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-05-13 |
Device Publish Date | 2019-01-08 |
B70712823000005A0 | PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Lateral Width: 21.1 mm Superior - Inferior Height |
B707128230000050 | PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Collapsed Width (mm): 12.32 Expanded Width (mm): 2 |
B707128220000050 | PLIF IMPLANT Lordosis & Heights: 8° x 9-12mm Collapsed Width (mm): 12.32 Expanded Width (mm): 2 |