Primus

Primary DI
00840466901820
Brand
Primus
Company
SPINAL ELEMENTS, INC.
Model
66023-095-120
Device description
9.5mm x 120mm, Primus DualFix
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840466901820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840466901820008404669018208404669018200840466901820

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7606070121customerservice@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840466901035Primus66019-0452026-07-21
00840466901042Primus66020-0452026-07-21
00840466901059Primus66021-0452026-07-21
00840466901066Primus66022-0452026-07-21
00840466901073Primus66024-0452026-07-21
00840466901080Primus66025-0452026-07-21
00840466901097Primus66026-0452026-07-21
00840466901103Primus66523-065-0452026-07-21
00840466901110Primus66009-0452026-07-21
00840466901127Primus66010-0452026-07-21
00840466901141Primus66012-0452026-07-21
00840466901158Primus66014-0452026-07-21
00840466901165Primus66015-0452026-07-21
00840466901172Primus66016-0452026-07-21
00840466901479Primus66023-075-0302026-07-21
00840466901486Primus66023-075-0352026-07-21
00840466901493Primus66023-075-0402026-07-21
00840466901509Primus66023-075-0452026-07-21
00840466901516Primus66023-075-0502026-07-21
00840466901523Primus66023-075-0552026-07-21

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Primary DI, Brand, Company table
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00197157082420ZAVATION SCREWZavation LLCKWP2026-07-23