FDA.reportPublic FDA data

4.0mm Dual Obturator

Primary DI
10850070500491
Brand
4.0mm Dual Obturator
Company
CURVAFIX, INC.
Model
OBT-001-LP
Catalog number
OBT-001-LP
Device description
Fits within all drills and cannulated instruments to keep pins and wires in place.
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
HXOPusher, Socket

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXOPusher, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850070500491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085007050049110850070500491

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide obturatorA surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a high-grade stainless steel. 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
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04262494460739N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460746N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460753N/ADoppkon GmbH & Co. KGHXO2025-09-10
04052536081417uCentumUlrich GmbH & Co. KGHXO2025-07-30
10810128461310Hip, Curved Knot PusherT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXO2025-04-29
08800089448739Surgical InstrumentJeil Medical CorporationHXO2024-11-14
00887868582134Affixus®Zimmer, Inc.HXO2024-10-17
00887868582325Affixus®Zimmer, Inc.HXO2024-10-17
08800247360118ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.HXO2024-04-26
04719878786768“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2024-04-15
00613994594891Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXO2023-07-27
08809763500411MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
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08809763501432MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763505317MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500176MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763500183MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
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08809763505188MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
00887868567490Closed Knot PusherBiomet Orthopedics, LLCHXO2023-05-29
06970399633780RapidLinkHangzhou Rejoin Mastin Medical Device Co., Ltd.HXO2023-05-22