FDA.reportPublic FDA data

NITINOL K WIRE TROCAR PIN

Primary DI
B09911067210
Brand
NITINOL K WIRE TROCAR PIN
Company
SONTEC INSTRUMENTS, INC.
Model
1106-721
Device description
NITINOL K WIRE TROCAR PIN 500MM X 1.5MM
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100736000KIRSCHNER AND GUIDE WIRESSmt Schilling Metalltechnik GmbH2010-09-10HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B09911067210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clavicle fixation pinA small-diameter rod used for the fixation of a bone fracture or bone grafts, an osteotomy, or an arthrodesis, in the presence of additional immobilization, typically to treat midshaft fractures, nonunions, and malunions of the clavicle bone. The rod may be smooth or partially-threaded and may be fitted with a securing nut and is capable of being fitted into the intramedullary canal of the clavicle through a small incision. It is typically made of surgical stainless steel. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length500Millimeter
Width1.5Millimeter

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-821-7496INFO@SONTECINSTRUMENTS.COM

Regulatory Flags#

DUNS number
040729840
Device count
1
Lot or batch
true
Sterilization required before use
true

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