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
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
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