FDA.report

Spinal Hook System

Primary DI
08800015952750
Brand
Spinal Hook System
Company
U&I CORPORATION
Model
SH1110
Published
2017-11-02
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
false

Related Records

Product Codes

CodeName
HXCWRENCH

Product Code Classifications

CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800015952750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800015952750088000159527508800015952750

GMDN Terms

TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place.

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

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