FDA.reportPublic FDA data

PolyLock Midfoot

Primary DI
00840124521056
Brand
PolyLock Midfoot
Company
FUSION ORTHOPEDICS, LLC
Model
CD-LF-9002
Catalog number
CD-LF-9002
Device description
LapiForm Set Wire
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EJWClasp, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJWClasp, WireDental1

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
00840124521056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124521056008401245210568401245210560840124521056

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, single-useA thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use 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
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
H66819007201Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007301Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007401Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007501Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007601Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007701Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007801Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007901Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007200Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007300Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007400Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007500Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007600Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007700Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007800Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007900Keystone IndustriesKeystone IndustriesEJW2022-11-30