FDA.reportPublic FDA data

Sniper® Spine System

Primary DI
10840642106145
Brand
Sniper® Spine System
Company
Spine Wave, Inc.
Model
11-4300
Catalog number
11-4300
Device description
Rod Straight 5.5 x 300mm
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

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
10840642106145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064210614510840642106145

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length300Millimeter
Outer Diameter5.5Millimeter

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

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Primary DI, Brand, Company table
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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
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