FDA.report

CapSure® Spine System

Primary DI
10840642104233
Brand
CapSure® Spine System
Company
Spine Wave, Inc.
Model
11-3166
Catalog number
11-3166
Device description
Offset Connector Open 40mm
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
10840642104233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084064210423310840642104233

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at each end, into which screw heads/rods fit, 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 transverse connecting element to be attached to corresponding bilateral screw heads or rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

Device Sizes

TypeValueUnit
Length40Millimeter

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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