FDA.reportPublic FDA data

Redirect Handle

Primary DI
10850070500682
Brand
Redirect Handle
Company
CURVAFIX, INC.
Model
RTH-001-LP
Catalog number
RTH-001-LP
Device description
Custom reusable handle that connects to Redirect Shaft and actuates the shaft’s pull wire to deflect the shaft. Cannulated to allow passage of any CurvaFix single use wire.
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850070500682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085007050068210850070500682

GMDN Terms#

Term, Definition table
TermDefinition
Manual wire driverA hand-held manual surgical instrument (drill-like) designed to drive orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different thickness that are pointed for self-drilling) into fractured/deformed bones for their restoration. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
4252768800support@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
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
10855068008409Lock ActivatorCSA-001CSA-0012021-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327007114ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-25
07613327007558XIA 3Stryker CorporationLXH2019-11-25
07613327007565XIA 3Stryker CorporationLXH2019-11-25
07613327114881XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327121919XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327126273AVS Anchor-C Cervical Cage SystemStryker CorporationLXH2019-11-25
07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25
07613327261752DIAPASONStryker CorporationLXH2019-11-25
07613327261943O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261950O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261967O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261974O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261998O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262001O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262018O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262025O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262032O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262049O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262056O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262070O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262087O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262094O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262100CENTAURStryker CorporationLXH2019-11-25
07613327262285XIAStryker CorporationLXH2019-11-25
07613327263176XIA IIStryker CorporationLXH2019-11-25
07613327263183XIA IIStryker CorporationLXH2019-11-25
07613327263190XIA IIStryker CorporationLXH2019-11-25
07613327263220XIA IIStryker CorporationLXH2019-11-25