FDA.reportPublic FDA data

NAV SOLID TAP FOR 5.5mm FASTENER

Primary DI
00810097803541
Brand
NAV SOLID TAP FOR 5.5mm FASTENER
Company
Osteocentric Technologies, Inc.
Model
104-0112
Catalog number
104-0112
Device description
NAV SOLID TAP FOR 5.5mm FASTENER
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
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

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
00810097803541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097803541008100978035418100978035410810097803541

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. 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
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
00810097803589NAV OPEN T25 LOCKING DRIVER104-0033104-00332026-03-26
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
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10885862634351EquinoxeExactech, Inc.HWX2026-04-28
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
07640450868374PERLA ®SpineArt SAHWX2025-11-10
07640450868381PERLA ®SpineArt SAHWX2025-11-10
08800308480564INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480571INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480588INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480595INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480601INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
09120125220136Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220143Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220150Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220167Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220174Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220181Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220198Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220204Shark Screw® tapsurgebright GmbHHWX2025-09-16
07640177820464Neo Medical Pedicle Screw SystemNeo Medical SAHWX2023-01-25