Optetrak Logic

Basic Information

• Brand Name: Optetrak Logic
• Primary DI: 10885862005144
• Version / Model: 02-019-10-0060
• Catalog Number: 02-019-10-0060
• Company Name: Exactech, Inc.
• Labeler DUNS: 157565946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-18
• Public Version: 1
• Public Version Date: 2022-08-26
• Public Version Status: New
• Public Device Record Key: 82536b4d-b9b6-4a11-a5d8-e83d486120ab

Device Description

FEMORAL NOTCH GUIDE, LOGIC, SIZE 6

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
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61917	Osteotomy guide, reusable	A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885862005144	GS1

Premarket Submissions

Submission Number	Supplement Number
K033883	000
K093360	000
K123687	000
K140302	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			SIZE 6