FDA.reportPublic FDA data

Sniper® Spine System

Primary DI
10840642106480
Brand
Sniper® Spine System
Company
Spine Wave, Inc.
Model
11-4656
Catalog number
11-4656
Device description
Cannulated Extended Tab Pedicle Screw 6.5mm x 55mm
Published
2015-10-24
Public version status
Update
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152174000Sniper Spine SystemSpine Wave, Inc.2015-08-31MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840642106480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064210648010840642106480

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used 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 (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length55Millimeter
Outer Diameter6.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
203-944-9494GUDID@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
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
10840642174878Salvo® Spine System21-008521-00852026-04-13
10840642174892Salvo® Spine System21-008721-00872026-04-13
10840642174915Salvo® Spine System21-008921-00892026-04-13
10840642160703Salvo® Spine System11-864911-86492026-03-17
10840642134322Salvo® Spine System11-666411-66642026-01-30
10840642134339Salvo® Spine System11-666511-66652026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889929072943Inertia® Pedicle Screw SystemNEXXT SPINE, LLCMNI2026-08-26
00889929072943Inertia® Pedicle Screw SystemNEXXT SPINE, LLCMNH2026-08-26
M719IST80030C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80030C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80070C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80070C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80075C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80075C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80080C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80080C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80085C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80085C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80090C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80090C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80095C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80095C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18