Lever Action Plate System MCG-P1816
GUDID B666MCGP18160
1.8MM x 16MM LOCKING PEG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | B666MCGP18160 |
| NIH Device Record Key | e73bab48-57dd-4d9b-9e9a-93c9b04679f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lever Action Plate System |
| Version Model Number | 0 |
| Catalog Number | MCG-P1816 |
| Company DUNS | 078568266 |
| Company Name | MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC |
| 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 | 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 |
Customer Support Contacts
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com | |
| Phone | 3073156403 |
| support@mcginleyinnovations.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B666MCGP18160 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200834
FDA Product Code
| HRS | Plate, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
[B666MCGP18160]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-21 |
| Device Publish Date | 2023-06-13 |
On-Brand Devices [Lever Action Plate System]
| B666MCGP18240 | 1.8MM x 24MM LOCKING PEG |
| B666MCGP18220 | 1.8MM x 22MM LOCKING PEG |
| B666MCGP18200 | 1.8MM x 20MM LOCKING PEG |
| B666MCGP18180 | 1.8MM x 18MM LOCKING PEG |
| B666MCGP18160 | 1.8MM x 16MM LOCKING PEG |
| B666MCGP18140 | 1.8MM x 14MM LOCKING PEG |
| B666MCGP18130 | 1.8MM x 13MM LOCKING PEG |
| B666MCGP18120 | 1.8MM x 12MM LOCKING PEG |
| B666MCGP18110 | 1.8MM x 11MM LOCKING PEG |
| B666MCGP18100 | 1.8MM x 10MM Locking Peg |
| B666MCG90220 | SCREWDRIVER, SCREW FORCEPS |
| B666MCG90210 | SCREWDRIVER, T8, AO STYLE |
| B666MCG90200 | DRIVER HANDLE, RATCHETING, 6IN TORQUE LIMITING, AO STYLE |
Trademark Results [Lever Action Plate System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEVER ACTION PLATE SYSTEM 88776221 not registered Live/Pending |
McGinley Engineered Solutions, LLC 2020-01-28 |
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