FDA.reportPublic FDA data

15mm CurvaFix Hex Wrench

Primary DI
10850070500569
Brand
15mm CurvaFix Hex Wrench
Company
CURVAFIX, INC.
Model
CHW-001-LP
Catalog number
CHW-001-LP
Device description
Attaches to both inserters to hold counter torque when actuating lock tool.
Published
2025-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXCWrench

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850070500569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085007050056910850070500569

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
425-276-8800support@curvafix.com

Regulatory Flags#

DUNS number
039779098
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850070500682Redirect HandleRTH-001-LPRTH-001-LP2026-04-14
10850070500699Flexible Disposable Redirect ShaftRTS-001-LPRTS-001-LP2026-04-14
10850070500705Standard Disposable Redirect ShaftRTS-002-LPRTS-002-LP2026-04-14
10850070500712CurvaFix Redirect System Instrument SetCIS-008-LPCIS-008-LP2026-04-14
10850070500729Redirect System Sterilization TrayRST-001-LPRST-001-LP2026-04-14
10855068008867Bead Extractor, 8.0 mmRKG-001RKG-0012023-09-26
10855068008874Bead Extractor, 6.8 mmRKG-002RKG-0022023-09-26
10855068008485CountersinkCCB-002CCB-0022022-06-20
10855068008522Instrument Set (Case and Reusable Instruments)CIS-003CIS-0032022-06-20
10855068008331Implant Selection DeviceISD-001ISD-0012021-12-02
10855068008355Sterilization Case, Implant Selection DeviceCIC-002CIC-0022021-12-02
10855068008386Implant Selection Device SetCIS-002CIS-0022021-12-02
10855068008164Handled CannulaCHC-001CHC-0012021-08-11
10855068008188Guide Pin SleeveCCS-031CCS-0312021-08-11
1085506800819510.2 mm SleeveCCS-102CCS-1022021-08-11
10855068008218CountersinkCCB-001CCB-0012021-08-11
10855068008225Steerable Guide SleeveCGS-001CGS-0012021-08-11
10855068008348Inserter/ExtractorCIA-001CIA-0012021-08-11
10855068008362Quick DisconnectPQD-001PQD-0012021-08-11
10855068008393Instrument Sterilization CaseCIC-001CIC-0012021-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982362964NASynthes GmbHHXC2026-05-04
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10889981437794SpecialsSeaspine Orthopedics CorporationHXC2025-10-17
18059015376494ORTHOFIXORTHOFIX SRLHXC2025-03-31
18059015376029TRUELOK SYSTEMORTHOFIX SRLHXC2025-01-10
10840199540805Modified Kaufman Type Kidney ClampKOROS U.S.A., INC.HXC2024-01-31
08800068966230LOSPA Modular Knee SystemCorentec Co., LtdHXC2022-10-24
08800068964960LOSPA Modular Knee System Corentec Co., LtdHXC2022-10-23
10845854023976ULTRAPOWERConmed CorporationHXC2022-06-02
B07301K0360280Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
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B07301K0380850Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0381200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0381220Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B073K0380440Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
10886982195722NASynthes GmbHHXC2019-02-21
08809265159063Surgical InstrumentJeil Medical CorporationHXC2018-11-28