Tyber Medical 401-65446

GUDID M6954016544614

Tyber Medical LLC

Orthopaedic bone screw (non-sliding)
Primary Device IDM6954016544614
NIH Device Record Keyd841f04c-dc3e-45ff-9f7e-c4df7fb062d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyber Medical
Version Model NumberHeadless Ø6.5 x 46mm Full Thread Ti (Torx)
Catalog Number401-65446
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
HIBCCM6954016544614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


[M6954016544614]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-07-09
Device Publish Date2018-02-02

On-Brand Devices [Tyber Medical]

M695502P281508S1PLIF 28mm x 8mm x 15mm x 0 °, TyPEEK, Sterile
M695502P2615812S1PLIF 26mm x 12mm x 15mm x 8 °, TyPEEK, Sterile
M695302P301521S1PLIF 30mm x 12mm x 15mm x 2 °, PEEK, Sterile
M695302P22808S1PLIF 22mm x 8mm x 8mm x 0 °, PEEK, Sterile
M69535141205120Cervical Curved 14 x 12 x 5 deg Trial
M69535141205110Cervical Curved 14 x 11 x 5 deg Trial
M69535141205100Cervical Curved 14 x 10 x 5 deg Trial
M69535141205090Cervical Curved 14 x 9 x 5 deg Trial
M69535141205080Cervical Curved 14 x 8 x 5 deg Trial
M69535141205070Cervical Curved 14 x 7 x 5 deg Trial
M69535141205060Cervical Curved 14 x 6 x 5 deg Trial
M69535141205050Cervical Curved 14 x 5 x 5 deg Trial
M69535000001210ANTERIOR INSERTER 6"
M69525261015080PLIF 26 x 15 x 8 deg Trial
M69525261013080PLIF 26 x 13 x 8 deg Trial
M69525261012080PLIF 26 x 12 x 8 deg Trial
M69525261011080PLIF 26 x 11 x 8 deg Trial
M69525261010080PLIF 26 x 10 x 8 ° Trial
M69525261009080PLIF 26 x 9 x 8 deg Trial
M69525261008080PLIF 26 x 8 x 8 deg Trial
M69525261007080PLIF 26 x 7 x 8 deg Trial
M69525000000690Offset Inserter 9"
M695250000000909" INSERTER
M695002T3090020TLIF Trial 30 x 10 x 9 x 0 deg
M695002T3080020TLIF Trial 30 x 10 x 8 x 0 deg
M695002T3070020TLIF Trial 30 x 10 x 7 x 0 deg
M695002T30170020TLIF 30 x 10 x 17x 0 DEG Trial
M695002T30140020TLIF Trial 30 x 10 x 14 x 0 deg
M695002T30130020TLIF Trial 30 x 10 x 13 x 0 deg
M695002T30120020TLIF Trial 30 x 10 x 12 x 0 deg
M695002T30110020TLIF Trial 30 x 10 x 11 x 0 deg
M695002T30100020TLIF Trial 30 x 10 x 10 x 0 deg
M695002T2890040TLIF 28 x 10 x 9 x 0° Trial
M695002T2880040TLIF 28 x 10 x 8 x 0° Trial
M695002T28120040TLIF 28 x 10 x 12 x 0° Trial
M695002T28110040TLIF 28 x 10 x 11 x 0° Trial
M695002T28100040TLIF 28 x 10 x 10 x 0° Trial
M695002P329080PLIF 32 x 9 x 0 deg Trial
M695002P328080PLIF 32 x 8 x 0 deg Trial
M695002P327080PLIF 32 x 7 x 0 deg Trial
M695002P3214080PLIF 32 x 14 x 0 deg Trial
M695002P3213080PLIF 32 x 13 x 0 deg Trial
M695002P3212080PLIF 32 x 12 x 0 deg Trial
M695002P3211080PLIF 32 x 11 x 0 deg Trial
M695002P3210080PLIF 32 x 10 x 0 deg Trial
M695002P289080PLIF 28 x 9 x 0 deg Trial
M695002P288080PLIF 28 x 8 x 0 deg Trial
M695002P287080PLIF 28 x 7 x 0 deg Trial
M695002P269880PLIF 26 x 9 x 8 ° Trial
M695002P26948026 x 9 x 4 Degree Trial, 8mm Wide

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