Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780235040
• Version / Model: PYROLUNINSTP
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 4
• Public Version Date: 2023-05-02
• Public Version Status: Update
• Public Device Record Key: aae4c5be-014d-4545-a2f0-84080a8239b0
• Distribution End Date: 2023-03-31

Device Description

The Integra Lunate system is intended for replacement of the lunate bone in the proximal carpal row of the wrist. The set includes five trials to evaluate the size and fit of the implant. Five sizing templates are also included to assess coverage and establish proper sizing for the component.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
KWN	PROSTHESIS, WRIST, CARPAL LUNATE	Orthopedic	888.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44758	General external orthopaedic fixation system implantation kit, reusable	A collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M268PYROLUNINSTP1	HIBCC
Primary	10381780235040	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080997	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			9.0 in L x 6.0 in W x 1.3 in H