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
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
00840124519244LapiLockTN-LL-5075TN-LL-50752025-05-14
00840124519251LapiLockTN-LL-5085TN-LL-50852025-05-14
00840124519268LapiLockTN-LL-5185TN-LL-51852025-05-14
00840124519275LapiLockTN-LL-5285TN-LL-52852025-05-14

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