FDA.report

Perfix™ Spinal System

Primary DI
08800037544735
Brand
Perfix™ Spinal System
Company
U&I CORPORATION
Model
SN0041
Published
2020-10-30
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
false

Related Records

Product Codes

CodeName
HXXSCREWDRIVER

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800037544735PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
688811082
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
08800037576057Perfix™ Spinal SystemSN00422023-06-01
08800037567277Dyna Locking Trochanteric NailNG23702023-05-23
08800037567284Dyna Locking Trochanteric NailNG23752023-05-23
08800037567291Dyna Locking Trochanteric NailNG23802023-05-23
08800037567307Dyna Locking Trochanteric NailNG23852023-05-23
08800037567314Dyna Locking Trochanteric NailNG23902023-05-23
08800037567321Dyna Locking Trochanteric NailNG23952023-05-23
08800037567338Dyna Locking Trochanteric NailNG24002023-05-23
08800037567345Dyna Locking Trochanteric NailNG24052023-05-23
08800037567352Dyna Locking Trochanteric NailNG24102023-05-23
08800037567369Dyna Locking Trochanteric NailNG24152023-05-23
08800037567376Dyna Locking Trochanteric NailNG24202023-05-23
08800037575845Dyna Locking Trochanteric NailNG09102023-05-23
08800037575852Dyna Locking Trochanteric NailNG09112023-05-23
08800037575869Dyna Locking Trochanteric NailNG09122023-05-23
08800037575876Dyna Locking Trochanteric NailNG09132023-05-23
08800037575883Dyna Locking Trochanteric NailNG09142023-05-23
08800037575890Dyna Locking Trochanteric NailNG09202023-05-23
08800037575906Dyna Locking Trochanteric NailNG09212023-05-23
08800037575913Dyna Locking Trochanteric NailNG09222023-05-23

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