FDA.reportPublic FDA data

LapiLock

Primary DI
00840124519268
Brand
LapiLock
Company
FUSION ORTHOPEDICS, LLC
Model
TN-LL-5185
Catalog number
TN-LL-5185
Device description
Right Cutting Block
Published
2025-05-14
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
LXIGuide, Drill, Ligament

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXIGuide, Drill, LigamentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124519268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124519268008401245192688401245192680840124519268

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. 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
G453332321055BC010PEAK MEDICALPeak Medical Distribution Inc.LXI2026-05-06
00888867500884Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500907Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500938Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500976Arthrex®ARTHREX, INC.LXI2026-03-13
00888867500990Arthrex®ARTHREX, INC.LXI2026-03-13
00840124521018PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-06-24
00840124519978PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519985PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520189PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520226PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520233PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520257PolyLock MidfootFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520264PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520325PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124520332PolyLock AnkleFUSION ORTHOPEDICS, LLCLXI2025-05-16
00840124519572PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519589PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519602PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519619PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519664PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519671PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519688PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519695PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519701PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519732PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519787PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519794PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519800PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15
00840124519831PolyLockFUSION ORTHOPEDICS, LLCLXI2025-05-15