FDA.reportPublic FDA data

Snap-Off Screw System Instruments

Primary DI
M6950100000010
Brand
Snap-Off Screw System Instruments
Company
Tyber Medical, LLC
Model
010-000001
Catalog number
010-000001
Device description
Snap Off Driver
Published
2019-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRZScrewdriver, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6950100000010PrimaryHIBCC0

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

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196449017645Anatomic Access LLIF818000362026-06-23
00196449035373Anatomic Access LLIF818000132026-06-23
00196449010134Anatomic Access LLIF818000292026-06-09
00196449010196Anatomic Access LLIF818000342026-06-09
00196449010288Anatomic Access LLIF818000352026-06-09
00196449035243Anatomic Access LLIF818000002026-06-09
00196449035250Anatomic Access LLIF818000012026-06-09
00196449035267Anatomic Access LLIF818000022026-06-09
00196449035281Anatomic Access LLIF818000042026-06-09
00196449035298Anatomic Access LLIF818000052026-06-09
00196449035304Anatomic Access LLIF818000062026-06-09
00196449035311Anatomic Access LLIF818000072026-06-09
00196449035328Anatomic Access LLIF818000082026-06-09
00196449035335Anatomic Access LLIF818000092026-06-09
00196449035366Anatomic Access LLIF818000122026-06-09
00196449035380Anatomic Access LLIF818000142026-06-09
00196449035397Anatomic Access LLIF818000152026-06-09
00196449035441Anatomic Access LLIF818000202026-06-09
00196449035465Anatomic Access LLIF818000222026-06-09
00196449035472Anatomic Access LLIF818000232026-06-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B8034709560ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
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B8034803550ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803560ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803580ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803600ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
B8034803620ORTHOMEDORTHO-MED, INC.LRZ2026-07-14
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00196449017393A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017454A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
00196449017553A.L.P.S. mvX™Tyber Medical, LLCLRZ2026-06-04
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