FDA.reportPublic FDA data

Metalogix

Primary DI
00840124521414
Brand
Metalogix
Company
FUSION ORTHOPEDICS, LLC
Model
900320
Catalog number
900320
Device description
(NOT IN PRODUCTION) Smooth Wire Spade Tip 2.0mm
Published
2025-09-30
Public version status
Update
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
QJDAbsorbable Metallic Bone Fixation Fastener

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJDAbsorbable Metallic Bone Fixation FastenerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124521414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124521414008401245214148401245214140840124521414

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
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
00840124521407MetalogixFUSION ORTHOPEDICS, LLCQJD2025-09-30
00840124521766MetalogixFUSION ORTHOPEDICS, LLCQJD2025-09-30
06438394015395RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015401RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015418RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015425RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015432RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015449RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015456RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015463RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12
06438394015470RemeOs™ Screw LAG SolidBioretec OyQJD2023-06-12