FDA.reportPublic FDA data

Cannulated Screw System +

Primary DI
00810040681974
Brand
Cannulated Screw System +
Company
Tyber Medical, LLC
Model
03.333.016S
Published
2020-05-21
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040681974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040681974008100406819748100406819740810040681974

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933jstigliano@tybermed.com

Regulatory Flags#

DUNS number
010968002
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810040684050Cannulated Compression Headless Screw03.333.31203.333.3122020-08-20
00196449021161VOLT™ Wrist Treatment System02.426.6452026-04-10
00196449021178VOLT™ Wrist Treatment System04.426.6452026-04-10
00196449021185VOLT™ Wrist Treatment System02.426.6462026-04-10
00196449021192VOLT™ Wrist Treatment System02.426.6472026-04-10
00196449021208VOLT™ Wrist Treatment System04.426.6462026-04-10
00196449021215VOLT™ Wrist Treatment System04.426.6472026-04-10
00196449021222VOLT™ Wrist Treatment System02.426.2502026-04-10
00196449021239VOLT™ Wrist Treatment System02.426.2552026-04-10
00196449021246VOLT™ Wrist Treatment System02.426.2602026-04-10
00196449021253VOLT™ Wrist Treatment System04.426.2502026-04-10
00196449021260VOLT™ Wrist Treatment System04.426.2552026-04-10
00196449021277VOLT™ Wrist Treatment System04.426.2602026-04-10
00196449021888VOLT™ Wrist Treatment System02.426.7332026-04-10
00196449021895VOLT™ Wrist Treatment System02.426.7322026-04-10
00196449021901VOLT™ Wrist Treatment System04.426.7332026-04-10
00196449021918VOLT™ Wrist Treatment System04.426.7322026-04-10
00196449021925VOLT™ Wrist Treatment System02.426.9112026-04-10
00196449021932VOLT™ Wrist Treatment System02.426.9102026-04-10
00196449021949VOLT™ Wrist Treatment System02.426.9212026-04-10

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Primary DI, Brand, Company table
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