FDA.reportPublic FDA data

Salvo® Spine System

Primary DI
10840642174656
Brand
Salvo® Spine System
Company
Spine Wave, Inc.
Model
21-0063
Catalog number
21-0063
Device description
9.5 x 70 mm Bone Screw, Cannulated, 3 mm Pitch
Published
2024-10-18
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182954000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182954000Salvo™ Spine SystemSpine Wave, Inc.2018-12-12NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840642174656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064217465610840642174656

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter
Outer Diameter9.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
203-944-9494info@spinewave.com

Regulatory Flags#

DUNS number
067789763
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840642168709Tornado™11-58052021-10-11
10840642159615Tornado™11-58002020-04-15
10840642159622Tornado™11-58012020-04-15
10840642159639Tornado™11-58022020-04-15
10840642159646Tornado™11-58032020-04-15
10840642159653Tornado™11-58042020-04-15
10840642134797Salvo® Spine System11-671111-67112026-07-16
10840642180299Proficient® Posterior Cervical Spine System10-813110-81312026-07-13
10840642180305Proficient® Posterior Cervical Spine System10-813210-81322026-07-13
10840642180312Proficient® Posterior Cervical Spine System10-813310-81332026-07-13
10840642180329Proficient® Posterior Cervical Spine System10-813410-81342026-07-13
10840642180336Proficient® Posterior Cervical Spine System10-813510-81352026-07-13
10840642180343Proficient® Posterior Cervical Spine System10-813610-81362026-07-13
10840642180350Proficient® Posterior Cervical Spine System10-813710-81372026-07-13
10840642107739Bifurcated Retractor Illuminator SWC-04SWC-042016-09-25
10840642174410Salvo® Spine System21-003921-00392026-04-13
10840642174434Salvo® Spine System21-004121-00412026-04-13
10840642174632Salvo® Spine System21-006121-00612026-04-13
10840642174649Salvo® Spine System21-006221-00622026-04-13
10840642174694Salvo® Spine System21-006721-00672026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157119447ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119454ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119461ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119478ZAVATION SCREWZavation LLCNKB2026-10-07
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00197157119492ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119508ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119515ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119522ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119539ZAVATION SCREWZavation LLCNKB2026-10-07
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00197157119553ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119560ZAVATION SCREWZavation LLCNKB2026-10-07
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00197157119584ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119591ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119607ZAVATION SCREWZavation LLCNKB2026-10-07
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00197157119096ZAVATION SCREWZavation LLCNKB2026-10-05