FDA.reportPublic FDA data

Proficient® Posterior Cervical Spine System

Primary DI
10840642125252
Brand
Proficient® Posterior Cervical Spine System
Company
Spine Wave, Inc.
Model
11-9336
Catalog number
11-9336
Device description
Smooth-Shank Screw, 3.8 mm × 36 mm
Published
2018-01-05
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

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
10840642125252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064212525210840642125252

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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536216710neon3Ulrich GmbH & Co. KGNKG2026-05-26
07290117356876CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
17290117356880CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
17290117356897CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-03-23
00763000990695INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC MINIMED, INC.NKG2026-03-22
00763000990701INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990718INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990725INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990732INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990749INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990756INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990763INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990770INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990787INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990794INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990800INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990817INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990824INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990831INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990848INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990855INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990862INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990879INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990886INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990893INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990909INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990916INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990923INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990930INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22
00763000990947INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-03-22