FDA.report

Pedicle Screw

Primary DI
B52310014755
Brand
Pedicle Screw
Company
Eisertech, LLC
Model
100147-55C
Catalog number
100147-55C
Device description
Modular Tulip 5.5 mm
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

Related Records

Product Codes

CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B52310014755PrimaryHIBCC0

GMDN Terms

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
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

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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
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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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