Device
SCREW 6543640 6.5MM FAS FOR 5.5 40MM LG
Manufacturer
MEDTRONIC SOFAMOR DANEK, INC.
Model: 6543640 DI: 00763000887292 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-08 Current Version: 2026-05-18
Description
SCREW 6543640 6.5MM FAS FOR 5.5 40MM LG
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 8e584309-5491-461a-8fe8-64b61fb8a059
Distribution Status: In Commercial Distribution
DUNS Number: 830350380
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00763000887292
Type: Primary
Issuing Agency: GS1
GMDN
Code: 46651
Name: Spinal bone screw, non-bioabsorbable
Definition:
A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
FDA Product Codes
NKB
Thoracolumbosacral pedicle screw system
KWQ
Appliance, fixation, spinal intervertebral body
MNH
Orthosis, spondylolisthesis spinal fixation
KWP
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
NQP
POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
MNI
Orthosis, spinal pedicle fixation
Premarket Submissions
Submission Number: K063083
Supplement Number: 000