FDA.reportPublic FDA data

QC T-Handle Quarter In Square

Primary DI
00816950029523
Brand
QC T-Handle Quarter In Square
Company
Osteocentric Technologies, Inc.
Model
110315
Catalog number
110315
Device description
QC T-Handle Quarter In Square
Published
2024-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver
JDODevice, Fixation, Proximal Femoral, Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1
JDODevice, Fixation, Proximal Femoral, ImplantOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210247000OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021-04-30JDO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816950029523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816950029523008169500295238169500295230816950029523

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
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
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

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