N/A

GUDID M695M1203190

Tyber Medical LLC

Orthopaedic bone screw (non-sliding)
Primary Device IDM695M1203190
NIH Device Record Key11c785fd-b5d3-453a-98c5-edaeadd07272
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberM1-20319
Company DUNS010968002
Company NameTyber Medical LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM695M1203190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-08-30
Device Publish Date2019-02-04

On-Brand Devices [N/A]

M695502T289504S0TLIF - 28mm x 10mm x 9mm x 5°
M695502T288504S0TLIF - 28mm x 10mm x 8mm x 5°
M695502T2812504S0TLIF - 28mm x 10mm x 12mm x 5°
M695502T2811504S0TLIF - 28mm x 10mm x 11mm x 5°
M695502T2810504S0TLIF - 28mm x 10mm x 10mm x 5°
M695502C14852S0ACIF - 14mm x 8mm x 5° Curvo
M695502C14752S0ACIF - 14mm x 7mm x 5° Curvo
M695502C14652S0ACIF - 14mm x 6mm x 5° Curvo
M695502C14552S0ACIF - 14mm x 5mm x 5° Curvo
M695M9654900M9-65490
M695M9654850M9-65485
M695M9654800M9-65480
M695M9654700M9-65470
M695M9654650M9-65465
M695M9654600M9-65460
M695M9654580M9-65458
M695M9654560M9-65456
M695M9654540M9-65454
M695M9654520M9-65452
M695M9654500M9-65450
M695M9654480M9-65448
M695M9654460M9-65446
M695M9654440M9-65444
M695M9654420M9-65442
M695M9654400M9-65440
M695M9654380M9-65438
M695M9654360M9-65436
M695M9654340M9-65434
M695M9654320M9-65432
M695M9654300M9-65430
M695M9653950M9-65395
M695M9653900M9-65390
M695M9653850M9-65385
M695M9653800M9-65380
M695M9653750M9-65375
M695M9653700M9-65370
M695M9653650M9-65365
M695M9653600M9-65360
M695M9653580M9-65358
M695M9653560M9-65356
M695M9653540M9-65354
M695M9653520M9-65352
M695M9653500M9-65350
M695M9653480M9-65348
M695M9653460M9-65346
M695M9653440M9-65344
M695M9653420M9-65342
M695M9653380M9-65338
M695M9653360M9-65336
M695M9653320M9-65332

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