FDA.reportPublic FDA data

FuzeFix Mini

Primary DI
00840124518742
Brand
FuzeFix Mini
Company
FUSION ORTHOPEDICS, LLC
Model
TN-FX-9010
Catalog number
TN-FX-9010
Device description
Small Screw Holding Forceps
Published
2025-05-13
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
HTPFile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTPFileOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170038000FuzeFix Screw SystemFusion Orthopedics, LLC2017-08-07HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124518742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124518742008401245187428401245187420840124518742

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, tweezers-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use.

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
B382SD1832521590Surgical DirectSurgical Direct, Inc.HTP2026-07-31
B382SD1836S21590Surgical DirectSurgical Direct, Inc.HTP2026-07-31
B382SD1856S90Surgical DirectSurgical Direct, Inc.HTP2026-07-31
00840286860420Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HTP2026-07-10
00840286860413Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HTP2026-07-09
008401944974973P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HTP2026-06-10
10810128463574Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2026-05-13
10810128463581Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2026-05-13
06974940306642endophixSuzhou Endophix Co., Ltd.HTP2025-12-12
10818674026618Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
10818674026625Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
04047844052501INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844067390INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844099742INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
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00840286853965Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853972Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286841009TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-21
00840286855990TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856003TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
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00840286856027TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856034TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
04047844059852INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-05-09
04046826034801MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHTP2025-05-07
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