FDA.reportPublic FDA data

Salvo® Spine System

Primary DI
10840642174342
Brand
Salvo® Spine System
Company
Spine Wave, Inc.
Model
21-0032
Catalog number
21-0032
Device description
8.5 x 35 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
10840642174342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064217434210840642174342

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
Length35Millimeter
Outer Diameter8.5Millimeter

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
10840642132786Proficient® Posterior Cervical Spine System10-854610-85462026-10-21
10840642132793Proficient® Posterior Cervical Spine System10-854710-85472026-10-21
10840642149890Proficient® Posterior Cervical Spine System10-852910-85292026-10-21
10840642149906Proficient® Posterior Cervical Spine System10-853010-85302026-10-21
10840642151282Proficient® Posterior Cervical Spine System10-860910-86092026-10-21
10840642151305Proficient® Posterior Cervical Spine System10-861010-86102026-10-21
10840642151312Proficient® Posterior Cervical Spine System10-859610-85962026-10-21
10840642182149Spine Wave Instruments10-020510-02052026-10-21
10840642182156Spine Wave Instruments10-020610-02062026-10-21
10840642182163Spine Wave Instruments10-020710-02072026-10-21
10840642149838Proficient® Posterior Cervical Spine System10-8524.110-8524.12026-10-20
10840642149845Proficient® Posterior Cervical Spine System10-8524.210-8524.22026-10-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606190671PrimusSPINAL ELEMENTS, INC.NKB2026-10-26
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHNKB2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHNKB2026-10-26
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000749903CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
03701313009632KHEIRONS.M.A.I.ONKB2026-10-23
03701313009649KHEIRONS.M.A.I.ONKB2026-10-23
03701313009656KHEIRONS.M.A.I.ONKB2026-10-23
03701313009663KHEIRONS.M.A.I.ONKB2026-10-23
03701313009670KHEIRONS.M.A.I.ONKB2026-10-23
03701313009687KHEIRONS.M.A.I.ONKB2026-10-23
03701313009694KHEIRONS.M.A.I.ONKB2026-10-23
03701313009700KHEIRONS.M.A.I.ONKB2026-10-23
03701313009717KHEIRONS.M.A.I.ONKB2026-10-23
03701313009724KHEIRONS.M.A.I.ONKB2026-10-23
03701313009731KHEIRONS.M.A.I.ONKB2026-10-23
03701313009748KHEIRONS.M.A.I.ONKB2026-10-23
03701313009755KHEIRONS.M.A.I.ONKB2026-10-23
03701313009762KHEIRONS.M.A.I.ONKB2026-10-23
03701313009779KHEIRONS.M.A.I.ONKB2026-10-23
03701313009786KHEIRONS.M.A.I.ONKB2026-10-23
03701313009793KHEIRONS.M.A.I.ONKB2026-10-23
03701313009809KHEIRONS.M.A.I.ONKB2026-10-23
03701313010027KHEIRONS.M.A.I.ONKB2026-10-23
03701313010034KHEIRONS.M.A.I.ONKB2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.NKB2026-10-22