FDA.reportPublic FDA data

PolyLock Midfoot

Primary DI
00840124525238
Brand
PolyLock Midfoot
Company
FUSION ORTHOPEDICS, LLC
Model
TN-TR-0093
Catalog number
TN-TR-0093
Device description
Custom Tray Screw Caddy
Published
2026-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211843000PolyLock Plating SystemFusion Orthopedics2022-03-04HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124525238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124525238008401245252388401245252380840124525238

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080307067
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124526044FibFixFN-TH-4713FN-TH-47132026-09-25
00840124526051FibFixFN-TH-4713-SFN-TH-4713-S2026-09-25
00840124526068FibFixFN-TH-5713FN-TH-57132026-09-25
00840124526075FibFixFN-TH-5713-SFN-TH-5713-S2026-09-25
00840124516779FibFixTN-FN-9000TN-FN-90002026-04-09
00840124517783FibFixTN-FN-9000-STN-FN-9000-S2026-04-09
00840124521773PolyLock MidfootTN-CA-2501TN-CA-25012025-10-02
00840124521780PolyLock MidfootTN-CA-2004TN-CA-20042025-10-02
00840124521797PolyLock MidfootTN-CA-2003TN-CA-20032025-10-02
00840124521803PolyLock MidfootTN-CA-2002TN-CA-20022025-10-02
00840124521810PolyLock MidfootTN-CA-2001TN-CA-20012025-10-02
00840124521827PolyLock MidfootTN-CA-2503TN-CA-25032025-10-02
00840124521834PolyLock MidfootTN-CA-2502TN-CA-25022025-10-02
00840124521841PolyLock MidfootTN-CA-2504TN-CA-25042025-10-02
00840124525467FibFixTN-FN-9000-ATN-FN-9000-A2026-04-09
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00840124519220IntraLockTN-LL-5861TN-LL-58612025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542033HALYARDMEDICAL ACTION INDUSTRIES INC.OJH2026-10-28
10809160542187HalyardMEDICAL ACTION INDUSTRIES INC.OJH2026-10-28
10809160541876HalyardMEDICAL ACTION INDUSTRIES INC.OJH2026-10-27
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10198956576940CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
10198956591981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
10198956598003CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
10198956600263CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
10198956603820CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
10198956614642CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
10198956619531CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
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10198956621503CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
10198956621527CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
10198956625310CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-26
10198956201606CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956487918CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956505766CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956508682CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956553552CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956572140CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956572171CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956572270CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956574427CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956581111CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956581791CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956584723CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956585829CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23
10198956585843CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-23