FDA.reportPublic FDA data

PolyLock Midfoot

Primary DI
00840124525092
Brand
PolyLock Midfoot
Company
FUSION ORTHOPEDICS, LLC
Model
TN-TR-0082
Catalog number
TN-TR-0082
Device description
Calc Fracture Tray
Published
2025-12-22
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
00840124525092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124525092008401245250928401245250920840124525092

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
00840124525603FibFixCD-FN-4037-SCD-FN-4037-S2026-05-11
00840124525610FibFixCD-FN-4047-SCD-FN-4047-S2026-05-11
00840124525627FibFixCD-FN-4057-SCD-FN-4057-S2026-05-11
00840124525634FibFixCD-FN-4037CD-FN-40372026-05-11
00840124525641FibFixCD-FN-4047CD-FN-40472026-05-11
00840124525658FibFixCD-FN-4057CD-FN-40572026-05-11
00840124521407Metalogix9003179003172025-09-30
00840124521414Metalogix9003209003202025-09-30
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525573FuzeFix LargeTN-FT-7070TN-FT-70702026-04-23
00840124525580FuzeFix LargeTN-FT-7024TN-FT-70242026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00819034022557TalarLift STS CD-TL-5050CD-TL-50502019-04-29
00840124525535Metalogix RevolutionTN-TR-0092TN-TR-00922026-04-17
00840124516113FibFixFN-SS-4014FN-SS-40142026-04-09
00840124516120FibFixFN-SS-40162026-04-09
00840124516137FibFixFN-SS-4018FN-SS-40182026-04-09
00840124516144FibFixFN-SS-4020FN-SS-40202026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956101524CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
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10198956362147CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956371040CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956372641CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956379008CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956385689CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956391604CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956423756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956447974CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956462243CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956464957CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956465756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956467330CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
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10198956487529CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956488588CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956489981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956490079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956490185CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956490741CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956491007CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956491144CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956492523CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956492639CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956492899CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03