FDA.reportPublic FDA data

PolyLock Midfoot

Primary DI
00840124521025
Brand
PolyLock Midfoot
Company
FUSION ORTHOPEDICS, LLC
Model
TN-LF-9503
Catalog number
TN-LF-9503
Device description
LapiForm Jig Right
Published
2025-06-24
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
NNOJig, Piston Cutting, Ent, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNOJig, Piston Cutting, Ent, Non-SterileEar, Nose, Throat1

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
00840124521025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124521025008401245210258401245210250840124521025

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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
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
00840124524743FuzeFix Max FTFUSION ORTHOPEDICS, LLCNNO2025-11-03
00840124524750FuzeFix Max FTFUSION ORTHOPEDICS, LLCNNO2025-11-03
00840124521681FuzeFix Max FTFUSION ORTHOPEDICS, LLCNNO2025-09-17
00840124521698FuzeFix Max FTFUSION ORTHOPEDICS, LLCNNO2025-09-17
00840124521032PolyLock MidfootFUSION ORTHOPEDICS, LLCNNO2025-06-24
09120034308000Drill BlockI.T.S. GmbHNNO2018-11-13
09120034308017Drill BlockI.T.S. GmbHNNO2018-11-13
09120034309854Drill BlockI.T.S. GmbHNNO2018-11-13
09120034309861Drill BlockI.T.S. GmbHNNO2018-11-13
09120069810950Drill BlockI.T.S. GmbHNNO2018-11-13
09120034308550JigI.T.S. GmbHNNO2018-11-06
09120034308710JigI.T.S. GmbHNNO2018-11-06
09120047297056JigI.T.S. GmbHNNO2018-11-06
09120047297063JigI.T.S. GmbHNNO2018-11-06
09120047297148JigI.T.S. GmbHNNO2018-11-06
09120047297209JigI.T.S. GmbHNNO2018-11-06
09120047306093JigI.T.S. GmbHNNO2018-11-06
09120047306109JigI.T.S. GmbHNNO2018-11-06
09120047308264JigI.T.S. GmbHNNO2018-11-06
09120069811636JigI.T.S. GmbHNNO2018-11-06
09120069812794JigI.T.S. GmbHNNO2018-11-06
00681490038416N/AMEDTRONIC XOMED, INC.NNO2017-09-10