FDA.reportPublic FDA data

BIOARCH

Primary DI
00840420128928
Brand
BIOARCH
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
ST1112
Catalog number
ST1112
Published
2015-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

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
K070441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070441000METASURG SUBTALAR IMPLANTMetasurg2007-05-08HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420128928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420128928008404201289288404201289280840420128928

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
Device Size Text, specify0
Outer Diameter12Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797111089PROPHECY INCOMPASS33820300338203002026-06-23
00889797111096PROPHECY INCOMPASS33820302338203022026-06-23
00889797111102PROPHECY INCOMPASS33820303338203032026-06-23
00889797111119PROPHECY INCOMPASS33820304338203042026-06-23
00889797111126PROPHECY INCOMPASS33820305338203052026-06-23
00889797114820PROPHECY INCOMPASSPROPINCPROPINC2026-06-23
00889797114837PROPHECY INCOMPASSPROPINCFPROPINCF2026-06-23
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCHWC2026-07-17
07613327646825NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646832NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646849NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646856NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646863NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646870NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646887NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646894NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646900NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646917NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646931NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646948NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646955NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646962NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646979NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646986NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327646993NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647006NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647013NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647020NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647037NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647044NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
07613327647051NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647069NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647076NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647090NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647106NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647113NAStryker Leibinger GmbH & Co. KGHWC2026-07-17
37613327647120NAStryker Leibinger GmbH & Co. KGHWC2026-07-17