FDA.report

Proficient® Posterior Cervical Spine System

Primary DI
10840642122152
Brand
Proficient® Posterior Cervical Spine System
Company
Spine Wave, Inc.
Model
11-9884
Catalog number
11-9884
Device description
Cannulated Translational Screw, 3.8 mm × 32 mm
Published
2018-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840642122152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084064212215210840642122152

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
203-944-9494GUDID@spinewave.com

Regulatory Flags

DUNS number
067789763
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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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
10840642175370Annex® 2 Adjacent Level System13-826413-82642026-01-13
10840642175387Annex® 2 Adjacent Level System13-826513-82652026-01-13
10840642175394Annex® 2 Adjacent Level System13-826213-82622026-01-13
10840642176964Annex® 2 Adjacent Level System13-827313-82732026-01-13
10840642176971Annex® 2 Adjacent Level System13-827213-82722026-01-13
10840642178319Annex® 2 Adjacent Level System13-826613-82662026-01-13
10840642179330Annex® 2 Adjacent Level System13-826713-82672026-01-13
10840642135039Salvo® Spine System 11-673511-67352026-01-09
10840642135046Salvo® Spine System 11-673611-67362026-01-09

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