FDA.reportPublic FDA data

SPIRA®-A Integrated

Primary DI
B030SAZ00300
Brand
SPIRA®-A Integrated
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
SAZ-0030
Device description
SPIRA®-A Integrated, Lumbar Bone Anchor, 30mm
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
PHMIntervertebral Fusion Device With Bone Graft, Thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234077000SPIRA® Anterior Lumbar SpacersCamber Spine Technologies2024-07-12MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B030SAZ00300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (484) 427-7060quality@cambermedtech.com

Regulatory Flags#

DUNS number
054205979
Device count
1
DM exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B030SPO1530020VARIANTSPO-153-0022022-11-25
B030TLP420WR0Alcantara™ Thoracolumbar PlatingTLP-420WR2025-08-01
B030TLP422WR0Alcantara™ Thoracolumbar PlatingTLP-422WR2025-08-01
B030TLP424WR0Alcantara™ Thoracolumbar PlatingTLP-424WR2025-08-01
B030TLP426WR0Alcantara™ Thoracolumbar PlatingTLP-426WR2025-08-01
B030TLP428WR0Alcantara™ Thoracolumbar PlatingTLP-428WR2025-08-01
B030TLP430WR0Alcantara™ Thoracolumbar PlatingTLP-430WR2025-08-01
B030TLP432WR0Alcantara™ Thoracolumbar PlatingTLP-432WR2025-08-01
B030TLP434WR0Alcantara™ Thoracolumbar PlatingTLP-434WR2025-08-01
B030TLP436WR0Alcantara™ Thoracolumbar PlatingTLP-436WR2025-08-01
B030TLP438WR0Alcantara™ Thoracolumbar PlatingTLP-438WR2025-08-01
B030TLP440WR0Alcantara™ Thoracolumbar PlatingTLP-440WR2025-08-01
B030TLP1000Alcantara Thoracolumbar PlatingTLP-100NA2024-07-18
B030TLP2180Alcantara Thoracolumbar PlatingTLP-218NA2024-07-18
B030TLP2200Alcantara Thoracolumbar PlatingTLP-220NA2024-07-18
B030TLP2220Alcantara Thoracolumbar PlatingTLP-222NA2024-07-18
B030TLP2240Alcantara Thoracolumbar PlatingTLP-224NA2024-07-18
B030TLP2260Alcantara Thoracolumbar PlatingTLP-226NA2024-07-18
B030TLP2280Alcantara Thoracolumbar PlatingTLP-228NA2024-07-18
B030TLP2350Alcantara Thoracolumbar PlatingTLP-235NA2024-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
07613153046196AVS PLStryker CorporationOVD2015-09-14
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07613153046363AVS PLStryker CorporationMAX2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14
07613153046394AVS TLStryker CorporationMAX2015-09-14
07613153046400AVS TLStryker CorporationOVD2015-09-14
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07613153046417AVS TLStryker CorporationMAX2015-09-14
07613153046417AVS TLStryker CorporationOVD2015-09-14
07613153046424AVS TLStryker CorporationMAX2015-09-14