FDA.reportPublic FDA data

OsteoCentric Headless Compression System 1.5mm Hex Driver Shaft Cannulated

Primary DI
00850015496387
Brand
OsteoCentric Headless Compression System 1.5mm Hex Driver Shaft Cannulated
Company
Osteocentric Technologies, Inc.
Model
EX01-0032
Catalog number
EX01-0032
Device description
Headless Compression System 1.5mm Hex Driver Shaft Cannulated
Published
2023-02-15
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
HWCScrew, Fixation, Bone
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
HXXScrewdriverOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200259000Headless Compression Screw SystemOsteocentric Extremities, LLC2020-05-04HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015496387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015496387008500154963878500154963870850015496387

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100978037493.0mm GUIDE WIRE 355mm202-80600202-806002026-06-02
00810118210198Torque Wrench701-0019701-00192023-10-31
00810118210259.050 Driver, Short701-0025701-00252023-10-31
00810118210266.050 Driver, Long701-0026701-00262023-10-31
00810118210273.050 Driver, Latch701-0027701-00272023-10-31
00810118210280Thumb Knob701-0029701-00292023-10-31
00810118210327Latch Driver, 300 Series701-0033701-00332023-10-31
00810118210334Square Driver, 300 Series701-0034701-00342023-10-31
00810118210341Latch Driver, 400 Series701-0035701-00352023-10-31
00810118210358Square Driver, 400 Series701-0036701-00362023-10-31
00810118210365Ratchet Adapter701-0037701-00372023-10-31
008101182100063.7mm Tap701-0013701-00132023-10-30
008101182100134.2mm Tap701-0014701-00142023-10-30
008101182100205.5mm Tap701-0015701-00152023-10-30
00810118210129Drill Extender701-0009701-00092023-10-30
008101182101673.7mm Parallel Pin701-0016701-00162023-10-30
008101182101744.2mm Parallel Pin701-0017701-00172023-10-30
008101182101815.5mm Parallel Pin701-0018701-00182023-10-30
00810097803527NAV 3.5mm DRILL104-0003104-00032026-03-26
00810097803534NAV TAPERED PROBE104-0005104-00052026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD91449311010Surgical DirectSurgical Direct, Inc.HXX2026-10-28
07630894821714APTUSMedartis AGHWC2026-10-27
07630894821721APTUSMedartis AGHWC2026-10-27
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07630894821752APTUSMedartis AGHWC2026-10-27
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07630894821776APTUSMedartis AGHWC2026-10-27
07630894821783APTUSMedartis AGHWC2026-10-27
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07630894821806APTUSMedartis AGHWC2026-10-27
07630894821813APTUSMedartis AGHWC2026-10-27
07630894821820APTUSMedartis AGHWC2026-10-27
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07630894822094APTUSMedartis AGHWC2026-10-27
07630894822117APTUSMedartis AGHWC2026-10-27
07630894822131APTUSMedartis AGHWC2026-10-27
07630894822155APTUSMedartis AGHWC2026-10-27