FDA.reportPublic FDA data

Sniper® Spine System

Primary DI
10840642108101
Brand
Sniper® Spine System
Company
Spine Wave, Inc.
Model
10-4100.1
Catalog number
10-4100.1
Device description
Screw Extension, Outer Sleeve
Published
2016-09-24
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100605000MIS SYSTEMSpine Wave, Inc.2010-06-04MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840642108101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064210810110840642108101

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

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
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
04047844129418DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129425DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129555DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129562DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129579DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129586DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129593DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129609DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129616DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129623DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129630DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129647DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129654DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129661DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129678DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129685DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129692DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13