Starr Frame Half Pin

Primary DI
00854226007127
Brand
Starr Frame Half Pin
Company
STARR FRAME LLC
Model
SF-2375-6071
Catalog number
SF-2375-6071
Device description
Starr Frame Half Pin, 375 mm6mm, 375 x 70mm1 each
Published
2020-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDWPin, Fixation, Threaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082017000STARR FRAME STEINMANN PINStarr Frame, LLC2008-10-10HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854226007134PackageGS110In Commercial Distribution
00854226007127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854226007134008542260071348542260071340854226007134
00854226007127008542260071278542260071270854226007127

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length375Millimeter
Outer Diameter6Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
469-249-2090customerservice@starrframe.com

Regulatory Flags#

DUNS number
804185838
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854226007004Starr Frame Half PinSF-2500-6101SF-2500-61012017-02-28
00854226007035Starr Frame Half PinSF-2250-5051SF-2250-50512017-02-28
00854226007189Reinert Reduction Tool, 10.5mm, Low ProfileSF-8800-5017SF-8800-50172022-11-18
00854226007028Reinert Reduction Tool, 11mmSF-8800-5010SF-8800-50102019-04-05
00854226007059Reinert Reduction Tool, 10.5mmSF-8800-5015SF-8800-50152019-04-05
00854226007066Ball SpikeSF-8800-5020SF-8800-50202019-04-05
00854226007073HookSF-8800-5030SF-8800-50302019-04-05
00854226007080PaddleSF-8800-5040SF-8800-50402019-04-05
00854226007097Pry BarSF-8800-5050SF-8800-50502019-04-05
00854226007103Tommy BarSF-8800-5060SF-8800-50602019-04-05
00854226007110AL Quick ConnectorSF-8800-6010SF-8800-60102019-04-05
00854226007134Starr Frame Half PinSF-2375-6071SF-2375-60712020-09-14
00854226007011Starr Frame Half PinSF-2500-6101SF-2500-61012017-02-28
00854226007042Starr Frame Half PinSF-2250-5051SF-2250-50512017-02-28

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