FDA.reportPublic FDA data

NAV OPEN T25 LOCKING DRIVER

Primary DI
00810097803589
Brand
NAV OPEN T25 LOCKING DRIVER
Company
Osteocentric Technologies, Inc.
Model
104-0033
Catalog number
104-0033
Device description
NAV OPEN T25 LOCKING DRIVER
Published
2026-03-26
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
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250520000OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.2025-10-27OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810097803589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097803589008100978035898100978035890810097803589

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags#

DUNS number
089645059
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810097803527NAV 3.5mm DRILL104-0003104-00032026-03-26
00810097803534NAV TAPERED PROBE104-0005104-00052026-03-26
00810097803541NAV SOLID TAP FOR 5.5mm FASTENER104-0112104-01122026-03-26
00810097803558NAV SOLID TAP FOR 6.5mm FASTENER104-0113104-01132026-03-26
00810097803565NAV SOLID TAP FOR 7.5mm FASTENER104-0114104-01142026-03-26
00810097803572NAV MIS T25 LOCKING DRIVER104-0031104-00312026-03-26
00810189110502IMPACTOR SHAFT324-0022324-00222025-09-22
00810189110519IMPACTOR TIP324-0032324-00322025-09-22
00816950029462Impactor317-0015317-00152021-05-07
008101891121481.8mm GUIDEWIRE, TROCAR TIP2004-01322004-01322025-12-19
00810097803756SMALL HUDSON POWER ADAPTER104-0006104-00062025-11-21
00810097803824TAB BREAKER BLOCK101-0037101-00372025-11-21
00810097803831RESCUE SLEEVE101-0038101-00382025-11-21
00810097803848SMALL HUDSON RATCHETING T-HANDLE101-0040101-00402025-11-21
00810097803855SOLID TAP FOR 5.5mm FASTENER101-0112101-01122025-11-21
00810097803862SOLID TAP FOR 6.5mm FASTENER101-0113101-01132025-11-21
00810097803879SOLID TAP FOR 7.5mm FASTENER101-0114101-01142025-11-21
008100743050134.0 x 125mm Drill Bit Cann AO320-80023320-800232024-12-06
00850015496240K-Wire 0.9mm, Smooth, Single TrocarEX01-0026EX01-00262020-06-11
00850015496257K-Wire 0.9mm, 20mm Threaded, Single TrocarEX01-0027EX01-00272020-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
09120125220228Shark Screw® driversurgebright GmbHHXX2025-09-16
08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24