FDA.reportPublic FDA data

OsteoMed

Primary DI
00842528126394
Brand
OsteoMed
Company
OSTEOMED LLC
Model
316-0554
Catalog number
316-0554
Device description
3.0/4.0mm T10 Driver, Cannulated, Short, Quick Release
Published
2021-04-27
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842528126394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842528126394008425281263948425281263940842528126394

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.1072Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Stored at controlled room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags#

DUNS number
606417780
Device count
1
DM exempt
true
Premarket exempt
true
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
00845694011815OsteoMed375-0008375-00082016-07-21
00845694041546OsteoMed320-2701320-27012016-07-21
00842528129722OsteoMed336-9101336-91012023-10-13
00842528129739OsteoMed336-9102336-91022023-10-13
00842528129746OsteoMed336-9103336-91032023-10-13
00842528129753OsteoMed336-9104336-91042023-10-13
00842528129760OsteoMed336-9105336-91052023-10-13
00842528129777OsteoMed336-9106336-91062023-10-13
00842528129784OsteoMed336-9107336-91072023-10-13
00842528129791OsteoMed336-9108336-91082023-10-13
00842528129807OsteoMed336-9109336-91092023-10-13
00842528129814OsteoMed336-9110336-91102023-10-13
00842528129821OsteoMed336-9111336-91112023-10-13
00842528129838OsteoMed336-9112336-91122023-10-13
00842528129845OsteoMed336-9201336-92012023-10-13
00842528129852OsteoMed336-9202336-92022023-10-13
00842528129869OsteoMed336-9203336-92032023-10-13
00842528129876OsteoMed336-9204336-92042023-10-13
00842528129883OsteoMed336-9205336-92052023-10-13
00842528129890OsteoMed336-9206336-92062023-10-13

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