FDA.reportPublic FDA data

Proficient® Posterior Cervical Spine System

Primary DI
10840642124088
Brand
Proficient® Posterior Cervical Spine System
Company
Spine Wave, Inc.
Model
21-8489
Catalog number
21-8489
Device description
Cannulated Smooth-Shank Translational Screw, 3.8 mm × 40 mm
Published
2018-01-10
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
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840642124088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064212408810840642124088

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.

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
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
10840642134346Salvo® Spine System11-666611-66662026-01-30
10840642177008Proficient® Posterior Cervical Spine System11-874411-87442026-01-15
10840642177794Proficient® Posterior Cervical Spine System11-874911-87492026-01-15
10840642175325Annex® 2 Adjacent Level System13-826813-82682026-01-13
10840642175332Annex® 2 Adjacent Level System13-826913-82692026-01-13
10840642175349Annex® 2 Adjacent Level System13-827013-82702026-01-13
10840642175356Annex® 2 Adjacent Level System13-827113-82712026-01-13
10840642175363Annex® 2 Adjacent Level System13-826313-82632026-01-13

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