FDA.reportPublic FDA data

6.5mm Disposable Cannulated Flexible Drill

Primary DI
10850070500019
Brand
6.5mm Disposable Cannulated Flexible Drill
Company
CURVAFIX, INC.
Model
CFR-065-LP
Catalog number
CFR-065-LP
Device description
A surgical drilling instrument (6.5mm diameter) intended to fit over the Steerable Guide or Drill Wire and creates a canal in the intramedullary space of the pelvic bones for Implant implantation. All sizes have front cutting features. Supplied in a single sterile barrier package placed in shelf carton
Published
2025-10-23
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850070500019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085007050001910850070500019

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-useA metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6.5Millimeter

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
Expiration date on label
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
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742341Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742358Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742365Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742372Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742389Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742396Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742402Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386747957Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-10-27
08053782780464BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
08053782780471BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
G79151202112817G0WishFIXRed Star Contract Manufacturing Inc.HTW2025-10-06
09120125220044Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220051Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220068Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220075Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220082Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220099Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220105Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220112Shark Screw® drillsurgebright GmbHHTW2025-09-16
08809416065601Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065618Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065625Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066905Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066912Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416068671Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24