FDA.reportPublic FDA data

PolyLock Midfoot

Primary DI
00840124521889
Brand
PolyLock Midfoot
Company
FUSION ORTHOPEDICS, LLC
Model
TN-CA-7003
Catalog number
TN-CA-7003
Device description
Calcaneus Spreader
Published
2025-10-02
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
LCJTissue Expander And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCJTissue Expander And AccessoriesUnknownU

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
00840124521889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124521889008401245218898401245218890840124521889

GMDN Terms#

Term, Definition table
TermDefinition
Horizontal non-powered traction systemAn assembly of devices designed to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae by means of attached harnesses whilst the patient typically lies in a supine position on the table during treatment. The assembly usually consists of several specialized harnesses, a combination of pulleys and cords, and a set of weights that hang from the cords as the source of the traction force (the patient's own weight or pneumatic devices may also be used). Adjustable spreader bars may be used to vary the angle at which the cord applies the traction. The assembly is used in orthopaedic and/or physical therapy procedures.

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00650551006084INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006176INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006237INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006503INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006510INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551005391INTEGRA®PMT CORPORATIONLCJ2025-03-26
10081317032332MENTOR CPX4 PLUS Enhance, Smooth, Tall HeightMENTOR TEXAS L.P.LCJ2025-03-26
00650551002154INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002161INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002772INTEGRA®PMT CORPORATIONLCJ2025-03-19
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00650551003311INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003328INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003335INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003410INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003427INTEGRA®PMT CORPORATIONLCJ2025-03-19