FDA.reportPublic FDA data

Implant Pin

Primary DI
00812926020389
Brand
Implant Pin
Company
Trilliant Surgical, LLC
Model
112-00-004
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K103183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103183000TRILLIANT SURGICAL SUBTALAR IMPLANTTrilliant Surgical, Ltd.2011-02-08HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926020389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926020389008129260203898129260203890812926020389

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446898795Arsenal Foot330-00-0112025-07-01
00190446898818Arsenal Foot330-27-0162025-07-01
00190446898825Arsenal Foot330-35-0162025-07-01
00190446898832Arsenal Foot330-00-0172025-07-01
00190446910091Arsenal Foot330-01-3012025-07-01
00190446910459Arsenal Foot330-01-3022025-07-01
00190446910466Arsenal Foot330-01-3032025-07-01
00190446910473Arsenal Foot330-01-3042025-07-01
00190446910480Arsenal Foot330-01-3052025-07-01
00190446910497Arsenal Foot330-01-3072025-07-01
00190446910503Arsenal Foot330-01-3082025-07-01
00810028395152Arsenal Ankle211-00-0082024-03-21
00810028391666Arsenal Ankle340-15-0032022-05-02
00810028391697Arsenal Ankle340-15-0072022-05-02
00810028391703Arsenal Ankle211-40-0012022-05-02
00810028391710Arsenal Ankle211-40-0022022-05-02
00810028391758Arsenal Ankle211-40-0042022-05-02
00810028391925Arsenal Ankle307-27-0422022-05-02
00810028391932Arsenal Ankle307-27-0442022-05-02
00810028391949Arsenal Ankle307-27-0462022-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09353903030461OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
09353903030478OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
09353903030485OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
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