FDA.reportPublic FDA data

FUSEFORCE

Primary DI
00840420127358
Brand
FUSEFORCE
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
FFNS1212
Catalog number
FFNS1212
Published
2015-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRSTAPLE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K124045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K124045000FUSEFORCE IMPLANT SYSTEMSolana Surgical, LLC2013-07-10JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420127358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420127358008404201273588404201273580840420127358

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter
Width12Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797114820PROPHECY INCOMPASSPROPINCPROPINC2026-06-23
00889797114837PROPHECY INCOMPASSPROPINCFPROPINCF2026-06-23
00889797102353PROPHECY™ INFINITY™PROPINFFPROPINFF2022-05-25
00889797057110PROPHECY INBONEPROPINBPROPINB2016-10-27
00889797057134PROPHECY INFINITYPROPINFPROPINF2016-10-27
00840420185662PROPHECYPROPRPTPROPRPT2017-03-20
00840420194725PROPHECY INVISIONPROPINVPROPINV2018-02-14
00889797103695PROSTEP™ MICA™57790009577900092022-02-01
00889797103718PROSTEP™ MICA™57790011577900112022-02-01
00889797111089PROPHECY INCOMPASS33820300338203002026-06-23
00889797111096PROPHECY INCOMPASS33820302338203022026-06-23
00889797111102PROPHECY INCOMPASS33820303338203032026-06-23
00889797111119PROPHECY INCOMPASS33820304338203042026-06-23
00889797111126PROPHECY INCOMPASS33820305338203052026-06-23
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867574342Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574359Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574366Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574373Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574380Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574397Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574403Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574410Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574427Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574434Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574441Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574458Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574465Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574595Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574601Arthrex®ARTHREX, INC.JDR2026-09-18
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
00810135964180VertexNVision Biomedical Technologies, Inc.JDR2025-12-17
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCJDR2025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCJDR2025-09-19
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
07630037889397APTUSMedartis AGJDR2023-03-03
00810005661010VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661027VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661034VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661041VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661058VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661065VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661072VertexNVision Biomedical Technologies, Inc.JDR2020-12-28