FDA.reportPublic FDA data

Cannulated Depth Guage

Primary DI
10850070500484
Brand
Cannulated Depth Guage
Company
CURVAFIX, INC.
Model
ISD-002-LP
Catalog number
ISD-002-LP
Device description
Measurement device used in combination with steerable guide markings to determine correct Implant size appropriate to the procedure.
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
HTJGauge, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850070500484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085007050048410850070500484

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

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
08809513720045SAEHAN Hydraulic Pinch GaugeSaehan CorporationHTJ2026-05-18
08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
08800071006862Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
08809539690667Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
10840199512703Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10840199513670Multi Level Black Belt Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10885862573483EPICExactech, Inc.HTJ2024-01-08
07708604560472SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHTJ2023-01-18
08055727374561DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
08055727374578DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
10603295550273INHANCEDEPUY (IRELAND)HTJ2022-12-09
10855068008331Implant Selection DeviceCURVAFIX, INC.HTJ2021-12-02
08800089415298INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089415328INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089417230INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089418350INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089418374INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089402762Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
08800089402779Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
08800089402830Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
M684E15000401EVOLUTIONMicroport Orthopedics Inc.HTJ2019-12-23
08806390873765VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-12-17
08806390863247Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390865869Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390867764Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390857963VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28
08806390859219VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28
08806390860031VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28
08806390862592Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28
10603295081982NADEPUY ORTHOPAEDICS, INC.HTJ2018-09-24