FDA.reportPublic FDA data

Simpex Steinmann Pin

Primary DI
B068D093S1
Brand
Simpex Steinmann Pin
Company
SIMPEX MEDICAL, INC.
Model
D-093-S
Catalog number
D-093-S
Device description
"Smooth Steinmann Pin, Single Diamond Tip; 3/32"" DIA x 9"" LG; Material: 316L Stainless Steel"
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K911452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911452000FIXATION PINSimpex, Inc.1991-04-12HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B068D093S1PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length229Millimeter
Outer Diameter2.4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-851-9753info@simpexmedical.com

Regulatory Flags#

DUNS number
932637023
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B068B125121Simpex Steinmann PinB-125-12B-125-122016-09-26
B068D0781Simpex Steinmann PinD-078D-0782015-09-23
B068D078121Simpex Steinmann PinD-078-12D-078-122015-09-23
B068D07812S1Simpex Steinmann PinD-078-12SD-078-12S2015-09-23
B068D078S1Simpex Steinmann PinD-078-SD-078-S2015-09-23
B068D0931Simpex Steinmann PinD-093D-0932015-09-23
B068D093121Simpex Steinmann PinD-093-12D-093-122015-09-23
B068D09312S1Simpex Steinmann PinD-093-12SD-093-12S2015-09-23
B068D1091Simpex Steinmann PinD-109D-1092015-09-23
B068D109121Simpex Steinmann PinD-109-12D-109-122015-09-23
B068D10912S1Simpex Steinmann PinD-109-12SD-109-12S2015-09-23
B068D109S1Simpex Steinmann PinD-109-SD-109-S2015-09-23
B068D1251Simpex Steinmann PinD-125D-1252015-09-23
B068D125121Simpex Steinmann PinD-125-12D-125-122015-09-23
B068D12512S1Simpex Steinmann PinD-125-12SD-125-12S2015-09-23
B068D125S1Simpex Steinmann PinD-125-SD-125-S2015-09-23
B068D1401Simpex Steinmann PinD-140D-1402015-09-23
B068D140121Simpex Steinmann PinD-140-12D-140-122015-09-23
B068D14012S1Simpex Steinmann PinD-140-12SD-140-12S2015-09-23
B068D140S1Simpex Steinmann PinD-140-SD-140-S2015-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436711MilleniumAvalign Technologies, Inc.HTY2026-10-20
05055662968538Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-10-16
09353903004240FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
09353903004257FO NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-10-12
M791TPK1237HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
M791TPK1253HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
00840536824974PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824981PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825025PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00190776405960MillenniumAvalign Technologies, Inc.HTY2026-07-28
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22