FDA.reportPublic FDA data

HORIZON TITANIUM SUBTALAR 8MM

Primary DI
00810012480291
Brand
HORIZON TITANIUM SUBTALAR 8MM
Company
BIOPRO, INC.
Model
17221
Published
2021-06-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
K041936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041936000BIOPRO SUBTALAR IMPLANTBiopro, Inc.2004-09-08HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810012480291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810012480291008100124802918100124802910810012480291

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209232920Rose Dorsal Plate232922026-10-27
M209232930Rose Plantar Plate232932026-10-27
M209232940Rose Proximal Cutting Guide232942026-10-27
M20923295Rose Distal Cutting Guide232952026-10-27
M209169570ACCU-CUT™ TWO STAGE169572015-09-16
M209169580ACCU-CUT™ TWO STAGE S169582015-09-16
M209173000ACCU-CUT™ 3mm OFFSET173002015-09-16
M209173060ACCU-CUT™ 3mm OFFSET S173062015-09-16
M209175020ACCU-CUT™ STANDARD W/2 BLADES175022015-09-16
M209175030ACCU-CUT™ 1mm OFFSET W/2 BLADES175032015-09-16
M209175040ACCU-CUT™ 2mm OFFSET W/2 BLADES175042015-09-16
M209175050ACCU-CUT™ 3mm OFFSET W/2 BLADES175052015-09-16
M209175060ACCU-CUT™ TWO STAGE W/2 BLADES175062015-09-16
M209177210ACCU-CUT™ STD MICRO CHOICE177212015-09-16
M209177330ACCU-CUT™ 1 mm MICRO CHOICE177332015-09-16
M209177340ACCU-CUT™ 2 mm MICRO CHOICE177342015-09-16
M209177350ACCU-CUT™ TWO STAGE MICRO177352015-09-16
M209185780ACCU-CUT™ 2mm W/THREADED K-WIRES185782015-09-16
M209195050ACCU-CUT™ STANDARD195052015-09-16
M209195060ACCU-CUT™ 1MM195062015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07630894821721APTUSMedartis AGHWC2026-10-27
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07630894821776APTUSMedartis AGHWC2026-10-27
07630894821783APTUSMedartis AGHWC2026-10-27
07630894821790APTUSMedartis AGHWC2026-10-27
07630894821806APTUSMedartis AGHWC2026-10-27
07630894821813APTUSMedartis AGHWC2026-10-27
07630894821820APTUSMedartis AGHWC2026-10-27
07630894821837APTUSMedartis AGHWC2026-10-27
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07630894821899APTUSMedartis AGHWC2026-10-27
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07630894822070APTUSMedartis AGHWC2026-10-27
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07630894822131APTUSMedartis AGHWC2026-10-27
07630894822155APTUSMedartis AGHWC2026-10-27
07630894822179APTUSMedartis AGHWC2026-10-27