APEX Spine System

Basic Information

• Brand Name: APEX Spine System
• Primary DI: M824PR64725F1
• Version / Model: PR6-4725-F
• Company Name: SPINECRAFT, LLC
• Labeler DUNS: 783908713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3c83b86d-97af-4920-b242-35c9cd0ae5b5

Device Description

Polyaxial Pedicle Reduction Screw, 4.75 x 25mm Self-Tapping

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: Yes
• 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
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION	Orthopedic	888.3070	2
MNH	Orthosis, spondylolisthesis spinal fixation	Orthopedic	888.3070	2
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	Orthopedic	888.3060	2
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease	Orthopedic	888.3070	2
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43257	Bone-screw internal spinal fixation system	An assembly of implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Disposable devices associated with implantation may be included.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M824PR64725F1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062513	000
K092825	000
K102488	000
K110906	000
K132603	000