Device
SCREW 6543635 6.5MM FAS FOR 5.5 35MM LG
Manufacturer
MEDTRONIC SOFAMOR DANEK, INC.
Model: 6543635 DI: 00763000887285 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 6543635 6.5MM FAS FOR 5.5 35MM 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: 90eb2e54-b0e8-47e5-84ea-f5ae481f88a1
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: 00763000887285
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
KWQ
Appliance, fixation, spinal intervertebral body
KWP
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
NQP
POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION
MNH
Orthosis, spondylolisthesis spinal fixation
NKB
Thoracolumbosacral pedicle screw system
MNI
Orthosis, spinal pedicle fixation
Premarket Submissions
Submission Number: K063083
Supplement Number: 000