FDA.reportPublic FDA data

11mm Disco Subtalar Implant

Primary DI
00812926020334
Brand
11mm Disco Subtalar Implant
Company
Trilliant Surgical, LLC
Model
102-20-011
Published
2017-01-27
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111834000DISCO SUBTALAR IMPLANTTrilliant Surgical, Ltd.2011-12-06HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926020334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926020334008129260203348129260203340812926020334

GMDN Terms#

Term, Definition table
TermDefinition
Subtalar implant, non-bioabsorbable, sterileA sterile device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height21Millimeter
Width11Millimeter

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
00812926027036Tiger210-00-1022018-09-23
00812926027890Tiger210-99-1122018-09-23
00812926028002Gridlock320-99-1132018-09-23
00812926028026Gridlock310-00-0212018-09-23
00190446972020Generic Instrument215-00-0072026-07-16
00190446972037Generic Instrument215-00-0082026-07-16
00190446900498Arsenal Foot330-60-0072026-06-25
00190446900504Arsenal Foot330-60-0082026-06-25
00190446917861Arsenal Foot330-01-2152026-06-25
00190446917878Arsenal Foot330-01-2162026-06-25
00190446932406Arsenal Foot330-22-0132026-06-25
00190446934196Arsenal Foot330-00-0242026-06-25
00190446934202Arsenal Foot330-00-0232026-06-25
00190446934417Arsenal Foot330-01-3062026-06-25
00190446934424Arsenal Foot330-01-3102026-06-25
00190446934431Arsenal Foot330-01-3092026-06-25
00190446934448Arsenal Foot330-01-2182026-06-25
00190446934455Arsenal Foot330-01-2172026-06-25
00190446944331Arsenal Foot300-85-0152026-06-25
00190446944348Arsenal Foot300-85-0162026-06-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
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