Apelo® / Apelo® MIS 1100-14-0065
GUDID M68111001400650
5.5mm x 65mm MIS Straight Rod
ATLAS SPINE, INC.
Spinal bone screw, non-bioabsorbable| Primary Device ID | M68111001400650 |
| NIH Device Record Key | 5843890b-f58f-4138-84b4-488d738fbc14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Apelo® / Apelo® MIS |
| Version Model Number | 1100-14-0065 |
| Catalog Number | 1100-14-0065 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Device Dimensions
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
| Length | 65 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68111001400650 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110842
FDA Product Code
| NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
[M68111001400650]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-09-03 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [Apelo® / Apelo® MIS]
| 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 |
Trademark Results [Apelo]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.