Primary Device ID | M68111001000350 |
NIH Device Record Key | 7b1836d3-81df-42f4-9d4e-c6b10c84ca1b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Apelo® / Apelo® MIS |
Version Model Number | 1100-10-0035 |
Catalog Number | 1100-10-0035 |
Company DUNS | 140801007 |
Company Name | ATLAS SPINE, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
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 | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com | |
Phone | (561) 741-1108 |
sales@atlasspine.com |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Length | 35 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M68111001000350 [Primary] |
NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
[M68111001000350]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-09-07 |
Device Publish Date | 2014-09-24 |
M68120108000000 | Fixed Rod Inserter |
M68120103200000 | Dual Tab Breaker |
M68120103100000 | Single Tab Breaker |
M68120100800000 | MIS Rod Inserter |
M68120100700000 | Cannulated Head Removal Tool |
M68120063200000 | Tab Removal Tool |
M68120060700000 | Head Removal Tool |
M68120100500000 | Cannulated Head Applicator |
M68120066800000 | Kerrison Rod Holder |
M68120065100000 | Curved Rod Holder |
M68120062800000 | Rod Holder |
M68120062700000 | Power Rod Gripper |
M68120060500000 | Head Applicator |
M68120100600000 | Cannulated Head Grooming Tool |
M68120060600000 | Head Grooming Tool |
M68169102307500 | 7.5mm Cannulated Screw Kit |
M68169102105500 | 5.5mm Cannulated Screw Kit |
M68169102004500 | 4.5mm Cannulated Screw Kit |
M68169101900000 | MIS Extended Head Kit |
M68169101800000 | MIS Head Kit |
M68169063306500 | 6.5mm Reduction Mono Screw Kit |
M68160060900000 | 5.5mm Reduction Head Kit |
M68160060300000 | 7.5mm Screw Kit |
M68160060100000 | 5.5mm Screw Kit |
M68120064000000 | Modular Screwdriver Sleeve |
M68120063300000 | T-Handle |
M68111100900090 | 9mm MIS Extended Head |
M68111100900050 | 5mm MIS Extended Head |
M68111100385550 | 8.5mm x 55mm Cannulated Reduction Mono Screw |
M68111100365600 | 6.5mm x 60mm Cannulated Reduction Mono Screw |
M68111100365550 | 6.5mm x 55mm Cannulated Reduction Mono Screw |
M68111100365500 | 6.5mm x 50mm Cannulated Reduction Mono Screw |
M68111100365450 | 6.5mm x 45mm Cannulated Reduction Mono Screw |
M68111100365400 | 6.5mm x 40mm Cannulated Reduction Mono Screw |
M68111100365350 | 6.5mm x 35mm Cannulated Reduction Mono Screw |
M68111100365300 | 6.5mm x 30mm Cannulated Reduction Mono Screw |
M68111100355250 | 5.5mm x 25mm Cannulated Reduction Mono Screw |
M68111100345450 | 4.5mm x 45mm Cannulated Reduction Mono Screw |
M68111100285500 | 8.5mm x 50mm Cannulated Mono Screw |
M68111100285300 | 8.5mm x 30mm Cannulated Mono Screw |
M68111100275600 | 7.5mm x 60mm Cannulated Mono Screw |
M68111100275450 | 7.5mm x 45mm Cannulated Mono Screw |
M68111100275350 | 7.5mm x 35mm Cannulated Mono Screw |
M68111100265250 | 6.5mm x 25mm Cannulated Mono Screw |
M68111100255450 | 5.5mm x 45mm Cannulated Mono Screw |
M68111100255400 | 5.5mm x 40mm Cannulated Mono Screw |
M68111100185550 | 8.5mm x 55mm Cannulated Modular Screw |
M68111100185350 | 8.5mm x 35mm Cannulated Modular Screw |
M68111100185300 | 8.5mm x 30mm Cannulated Modular Screw |
M68111100175350 | 7.5mm x 35mm Cannulated Modular Screw |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() APELO 79333922 not registered Live/Pending |
HELLA GmbH & Co. KGaA 2022-01-04 |
![]() APELO 77507710 3702801 Live/Registered |
Atlas Spine, Inc. 2008-06-25 |