FDA.reportPublic FDA data

Pedicle Screw

Primary DI
B5231000025025
Brand
Pedicle Screw
Company
Eisertech, LLC
Model
100002-5025C
Catalog number
100002-5025C
Device description
CANNULATED MODULAR PEDICLE SCREW 5.0 X 25
Published
2018-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5231000025025PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
965627297
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
B523100018121410Cervical Cage100018-121410100018-1214102017-04-06
B52310001812144Cervical Cage100018-12144100018-121442017-04-07
B52310001812145Cervical Cage100018-12145100018-121452017-04-07
B52310001812146Cervical Cage100018-12146100018-121462017-04-06
B52310001812147Cervical Cage100018-12147100018-121472017-04-06
B52310001812148Cervical Cage100018-12148100018-121482017-04-06
B52310001812149Cervical Cage100018-12149100018-121492017-04-06
B523100018141610Cervical Cage100018-141610100018-1416102017-04-06
B52310001814164Cervical Cage100018-14164100018-141642017-04-06
B52310001814165Cervical Cage100018-14165100018-141652017-04-06
B52310001814166Cervical Cage100018-14166100018-141662017-04-06
B52310001814167Cervical Cage100018-14167100018-141672017-04-06
B52310001814168Cervical Cage100018-14168100018-141682017-04-06
B52310001814169Cervical Cage100018-14169100018-141692017-04-06
B523100018161810Cervical Cage100018-161810100018-1618102017-04-06
B52310001816184Cervical Cage100018-16184100018-161842017-04-06
B52310001816185Cervical Cage100018-16185100018-161852017-04-07
B52310001816186Cervical Cage100018-16186100018-161862017-04-06
B52310001816187Cervical Cage100018-16187100018-161872017-04-06
B52310001816188Cervical Cage100018-16188100018-161882017-04-06

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Primary DI, Brand, Company table
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00840283402197VyPlate™VY SPINE LLCKWQ2026-03-19
00840283402203VyPlate™VY SPINE LLCKWQ2026-03-19
08800071055440ASTEROSTEONIC CO.,Ltd.KWQ2026-03-19
00763000889982VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000889999VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890001VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
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00763000890117VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890124VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890131VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
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00763000890186VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890193VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
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