FDA.reportPublic FDA data

SMALL HUDSON RATCHETING T-HANDLE

Primary DI
00810097803848
Brand
SMALL HUDSON RATCHETING T-HANDLE
Company
Osteocentric Technologies, Inc.
Model
101-0040
Catalog number
101-0040
Device description
SMALL HUDSON RATCHETING T-HANDLE
Published
2025-11-21
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221332000OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies2022-07-28NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810097803848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097803848008100978038488100978038480810097803848

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). 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
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
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

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