DEVICE: Valencia Pedicle Screw System (B41797365251)

Device Identifier (DI) Information

Valencia Pedicle Screw System
973-6525
In Commercial Distribution

Altus Spine, LLC
B41797365251
HIBCC

1
078331322 *Terms of Use
6.5mm x 25mm Triple Lead Multi-Axial Screw
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46651 Spinal bone screw, non-bioabsorbable
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.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNH Orthosis, spondylolisthesis spinal fixation
NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 25 Millimeter
Outer Diameter: 6.5 Millimeter
CLOSE

Device Record Status

947e6141-d030-40dd-bcc5-de4df43627ae
September 11, 2024
4
October 28, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
GS1 00843210115078
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(610)355-4156
Info@altus-spine.com
CLOSE