Excella II®

Basic Information

• Brand Name: Excella II®
• Primary DI: M711CL45570
• Version / Model: CL4557
• Catalog Number: CL4557
• Company Name: INNO Holdings, Inc.
• Labeler DUNS: 141620464
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-15
• Public Version: 7
• Public Version Date: 2025-12-31
• Public Version Status: Update
• Public Device Record Key: 57bb094a-bdc3-4eef-a0c7-ca8bd8abfe34

Device Description

Ti 6Al 4V (ELI)

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	888.3050	2
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	888.3060	2
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	888.3070	2
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	888.3070	2
NKB	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65114	Bone-screw internal spinal fixation system connector	An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M711CL45570	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Length 45 - 57mm