FDA.reportPublic FDA data

Starr Frame Half Pin

Primary DI
00854226007042
Brand
Starr Frame Half Pin
Company
STARR FRAME LLC
Model
SF-2250-5051
Catalog number
SF-2250-5051
Device description
Starr Frame Half Pin 5mm, 250 x 50mm 1 each
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00854226007042PackageGS110In Commercial Distribution
00854226007035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854226007042008542260070428542260070420854226007042
00854226007035008542260070358542260070350854226007035

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length250Millimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854226007189Reinert Reduction Tool, 10.5mm, Low ProfileSF-8800-5025SF-8800-50252022-11-18
00854226007134Starr Frame Half PinSF-2375-6071SF-2375-60712020-09-14
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
00854226007011Starr Frame Half PinSF-2500-6101SF-2500-61012017-02-28

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