FDA.report

Starr Frame Half Pin

Primary DI
00854226007134
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 mm 6mm, 375 x 70mm 1 each
Published
2020-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JDWPin, Fixation, Threaded

Product Code Classifications

CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions

SubmissionSupplement
K082017000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K082017000STARR FRAME STEINMANN PINStarr Frame, LLC2008-10-10HTY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00854226007134PackageGS110In Commercial Distribution
00854226007127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854226007134008542260071348542260071340854226007134
00854226007127008542260071278542260071270854226007127

GMDN Terms

TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes

TypeValueUnit
Length375Millimeter
Outer Diameter6Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
469-249-2090customerservice@starrframe.com

Regulatory Flags

DUNS number
804185838
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
true
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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