E3D-A Anchor System

Basic Information

• Brand Name: E3D-A Anchor System
• Primary DI: 00195860023297
• Version / Model: 112-A015
• Catalog Number: 112-A015
• Company Name: Evolution Spine LLC
• Labeler DUNS: 116940934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-24
• Public Version: 2
• Public Version Date: 2024-09-11
• Public Version Status: Update
• Public Device Record Key: 5572863a-843e-41a0-b70b-c81c2108aaeb

Device Description

E3D-A Anchor Inserter 15 mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAX	Intervertebral fusion device with bone graft, lumbar	Orthopedic	888.3080	2
OVD	Intervertebral fusion device with integrated fixation, lumbar	Orthopedic	888.3080	2
PHM	Intervertebral fusion device with bone graft, thoracic	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12696	Orthopaedic inorganic implant inserter/extractor, reusable	A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195860023297	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240368	000