FDA.reportPublic FDA data

Cervical Plate

Primary DI
B52310008840
Brand
Cervical Plate
Company
Eisertech, LLC
Model
100088-40
Catalog number
100088-40
Device description
Cervical Plate - 2 Level x 40mm
Published
2017-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113170000CERVICAL PLATEEisertech, LLC2012-04-06KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B52310008840PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
965627297
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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B5231003204530Pedicle Screw100320-4530D100320-4530D2019-08-19
B5231003204555Pedicle Screw100320-4555D100320-4555D2019-08-19
B5231003204560Pedicle Screw100320-4560D100320-4560D2019-08-19
B5231003205525Pedicle Screw100320-5525D100320-5525D2019-08-19
B5231003206525Pedicle Screw100320-6525D100320-6525D2019-08-19
B5231003206565Pedicle Screw100320-6565D100320-6565D2019-08-19
B5231003206570Pedicle Screw100320-6570D100320-6570D2019-08-19
B5231003207525Pedicle Screw100320-7525D100320-7525D2019-08-19
B5231003207565Pedicle Screw100320-7565D100320-7565D2019-08-19
B5231003207570Pedicle Screw100320-7570D100320-7570D2019-08-19
B5231003207575Pedicle Screw100320-7575D100320-7575D2019-08-19
B5231003207580Pedicle Screw100320-7580D100320-7580D2019-08-19
B5231003208570Pedicle Screw100320-8570D100320-8570D2019-08-19
B5231003208580Pedicle Screw100320-8580D100320-8580D2019-08-19
B5231003208590Pedicle Screw100320-8590D100320-8590D2019-08-19
B5231000024530Pedicle Screw100002-4530C100002-4530C2018-04-09
B5231000025025Pedicle Screw100002-5025C100002-5025C2018-04-09
B5231000025030Pedicle Screw100002-5030C100002-5030C2018-04-09
B5231000025035Pedicle Screw100002-5035C100002-5035C2018-04-09

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Primary DI, Brand, Company table
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