NA

Basic Information

• Brand Name: NA
• Primary DI: 10705034767390
• Version / Model: 299.277
• Catalog Number: 299277
• Company Name: SYNTHES (U.S.A.) LP
• Labeler DUNS: 832637081
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 3
• Public Version Date: 2024-07-12
• Public Version Status: Update
• Public Device Record Key: 02da06d6-90af-4ce3-abd0-fa7a04c8d857
• Distribution End Date: 2021-06-05

Device Description

DUAL-OPENING THORACIC LAMINA HOOK-FRONTAL FOR 6.0MM RODS

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: 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
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
65115	Bone-screw internal spinal fixation system hook	An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design 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)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H9812992770	HIBCC
Primary	10705034767390	GS1

Customer Contacts

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