FDA.report

CapSure® Spine System

Primary DI
10840642104202
Brand
CapSure® Spine System
Company
Spine Wave, Inc.
Model
11-3160
Catalog number
11-3160
Device description
Connector Locking Screw
Published
2015-10-24
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
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840642104202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084064210420210840642104202

GMDN Terms

TermDefinition
Spinal bone set screwA small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw (screw head), anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

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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