FDA.reportPublic FDA data

Primus

Primary DI
00840466901011
Brand
Primus
Company
SPINAL ELEMENTS, INC.
Model
66027-045
Device description
6.0mm x 45mm, Ti MIS Lordotic Rod
Published
2026-10-22
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
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243916000Primus Spinal Fixation SystemSpinal Elements, Inc.2025-02-21NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840466901011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840466901011008404669010118404669010110840466901011

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606168472SAPPHIRE X27002-0232026-10-22
00840606168502SAPPHIRE X27002-0292026-10-22
00840606174855Primus66102-0002026-10-22
00840606175142Primus66647-0002026-10-22
00840606175203Primus66656-0002026-10-22
00840606175234Primus66685-0002026-10-22
00840606176347Lucent11341-1122026-10-22
00840606184656Overwatch108-159-01C2026-10-22
00840606184847Lucent11341-5122026-10-22
00840606185820Primus66599-0002026-10-22
00840606185868Primus66675-0102026-10-22
00840606186506Lateral81077-0082026-10-22
00840606186513Lateral81077-0102026-10-22
00840606186575SAPPHIRE X27001-0002026-10-22
00840606186612SAPPHIRE X27001-000-042026-10-22
00840606186643SAPPHIRE X27001-000-072026-10-22
00840606186674SAPPHIRE X27001-000-102026-10-22
00840606186704SAPPHIRE X27001-000-132026-10-22
00840606186735SAPPHIRE X27001-000-162026-10-22
00840606186810SAPPHIRE X27000-001-012026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606168472SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-10-22
00840606168502SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-10-22
00840606174855PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175142PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175203PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606185868PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187527OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
03701313009823KHEIRONS.M.A.I.ONKB2026-10-22
03701313009830KHEIRONS.M.A.I.ONKB2026-10-22
03701313009854KHEIRONS.M.A.I.ONKB2026-10-22
03701313009878KHEIRONS.M.A.I.ONKB2026-10-22
03701313009885KHEIRONS.M.A.I.ONKB2026-10-22
03701313009892KHEIRONS.M.A.I.ONKB2026-10-22
03701313009908KHEIRONS.M.A.I.ONKB2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22
00197157123611ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123628ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123635ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123642ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123659ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123666ZAVATION SCREWZavation LLCNKB2026-10-21
00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122881ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20