Device
Ø8.5mm X 30mm DL MIS Pedicle Screw Assy
Manufacturer
Xtant Medical Holdings, Inc.
Model: 05-PA-85-30 Catalog: 05-PA-85-30 DI: 00840311246410 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
Ø8.5mm X 30mm DL MIS Pedicle Screw Assy
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: 229783bf-694c-4dfe-b4a6-d9b15a98e497
Distribution Status: In Commercial Distribution
DUNS Number: 081224143
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
Item #1 - Device ID: 00840311246410
Item #1 - Device ID Type: Primary
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00191083019864
Item #2 - Device ID Type: Previous
Item #2 - Device ID 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
MNI
Orthosis, spinal pedicle fixation
NKB
Thoracolumbosacral pedicle screw system
MNH
Orthosis, spondylolisthesis spinal fixation
Premarket Submissions
Submission Number: K192396
Supplement Number: 000