Primary Device ID | B528XL1814300 |
NIH Device Record Key | 20a0a1b2-bd7f-4d93-85f8-43d6393cf776 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Yellowstone |
Version Model Number | 1 |
Catalog Number | XL181430 |
Company DUNS | 071012634 |
Company Name | PANTHEON SPINAL, LLC |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com | |
Phone | 5123083488 |
info@pantheon-spinal.com |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Height | 18 Millimeter |
Length | 30 Millimeter |
Width | 14 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B528XL1814300 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
[B528XL1814300]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-03-22 |
Device Publish Date | 2021-03-12 |
B528100213010 | 13mm End Plate Scraper |
B528RXL0918500 | SPACER LATERAL 18X50MM PEEK |
B528RXL0918450 | SPACER LATERAL 18X45MM PEEK |
B528XL1214650 | Lateral Implant 12mm H x 14mm W x 65mm L - Parallel |
B528XL1214600 | Lateral Implant 12mm H x 14mm W x 60mm L - Parallel |
B528XL1214550 | Lateral Implant 12mm H x 14mm W x 55mm L - Parallel |
B528XL1214500 | Lateral Implant 12mm H x 14mm W x 50mm L - Parallel |
B528XL1214450 | Lateral Implant 12mm H x 14mm W x 45mm L - Parallel |
B528XL1214400 | Lateral Implant 12mm H x 14mm W x 40mm L - Parallel |
B528XL1214350 | Lateral Implant 12mm H x 14mm W x 35mm L - Parallel |
B528XL1214300 | Lateral Implant 12mm H x 14mm W x 30mm L - Parallel |
B528XL1214250 | Lateral Implant 12mm H x 14mm W x 25mm L - Parallel |
B528XL1214200 | Lateral Implant 12mm H x 14mm W x 20mm L - Parallel |
B528XL1014700 | Lateral Implant 10mm H x 14mm W x 70mm L - Parallel |
B528XL1014650 | Lateral Implant 10mm H x 14mm W x 65mm L - Parallel |
B528XL1014600 | Lateral Implant 10mm H x 14mm W x 60mm L - Parallel |
B528XL1014550 | Lateral Implant 10mm H x 14mm W x 55mm L - Parallel |
B528XL1014500 | Lateral Implant 10mm H x 14mm W x 50mm L - Parallel |
B528XL1014450 | Lateral Implant 10mm H x 14mm W x 45mm L - Parallel |
B528XL1014400 | Lateral Implant 10mm H x 14mm W x 40mm L - Parallel |
B528XL1014350 | Lateral Implant 10mm H x 14mm W x 35mm L - Parallel |
B528XL1014300 | Lateral Implant 10mm H x 14mm W x 30mm L - Parallel |
B528XL1014250 | Lateral Implant 10mm H x 14mm W x 25mm L - Parallel |
B528XL1014200 | Lateral Implant 10mm H x 14mm W x 20mm L - Parallel |
B528XL0814700 | Lateral Implant 8mm H x 14mm W x 70mm L - Parallel |
B528XL0814650 | Lateral Implant 8mm H x 14mm W x 65mm L - Parallel |
B528XL0814600 | Lateral Implant 8mm H x 14mm W x 60mm L - Parallel |
B528XL0814550 | Lateral Implant 8mm H x 14mm W x 55mm L - Parallel |
B528XL0814500 | Lateral Implant 8mm H x 14mm W x 50mm L - Parallel |
B528XL0814450 | Lateral Implant 8mm H x 14mm W x 45mm L - Parallel |
B528XL0814400 | Lateral Implant 8mm H x 14mm W x 40mm L - Parallel |
B528XL0814350 | Lateral Implant 8m H x 14mm W x 35mm L - Parallel |
B528XL0814300 | Lateral Implant, 8mm H x 14mm W x 30mm L - Parallel |
B528XL0814250 | Lateral Implant, 8mm H x 14mm W x 25mm L - Parallel |
B528XL0814200 | Lateral Implant, 8mm H x 14mm W x 20mm L - Parallel |
B528XL0614700 | Lateral Implant, 6mm H x 14mm W x 70mm L - Parallel |
B528XL0614650 | Lateral Implant, 6mm H x 14mm W x 65mm L - Parallel |
B528XL0614600 | Lateral Implant, 6mm H x 14mm W x 60mm L - Parallel |
B528XL0614550 | Lateral Implant, 6mm H x 14mm W x 55mm L - Parallel |
B528XL0614500 | Lateral Implant, 6mm H x 14mm W x 50mm L - Parallel |
B528XL0614450 | Lateral Implant, 6mm H x 14mm W x 45mm L - Parallel |
B528XL0614400 | Lateral Implant, 6mm H x 14mm W x 40mm L - Parallel |
B528XL0614350 | Lateral Implant, 6mm H x 14mm W x 35mm L - Parallel |
B528XL0614300 | Lateral Implant, 6mm H x 14mm W x 30mm L - Parallel |
B528XL0614250 | Lateral Implant, 6mm H x 14mm W x 25mm L - Parallel |
B528XL0614200 | Lateral Implant, 6mm H x 14mm W x 20mm L - Parallel |
B528XL1814500 | Lateral Implant 18mm H x 14mm W x 50mm L - Parallel |
B528XL1814450 | Lateral Implant 18mm H x 14mm W x 45mm L - Parallel |
B528XL1814400 | Lateral Implant 18mm H x 14mm W x 40mm L - Parallel |
B528XL1814350 | Lateral Implant 18mm H x 14mm W x 35mm L - Parallel |