FDA.reportPublic FDA data

FibFix

Primary DI
00840124521261
Brand
FibFix
Company
FUSION ORTHOPEDICS, LLC
Model
CD-FN-4000-S
Catalog number
CD-FN-4000-S
Device description
Instrument Procedural Kit (Sterile)
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252961000Fusion FibFix NailFusion Orthopedics USA, LLC2026-03-18HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124521261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124521261008401245212618401245212610840124521261

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, single-useAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation 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
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00840606185974ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186124ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186148ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26