Tyber Medical 35-14120505

GUDID M69535141205050

Cervical Curved 14 x 5 x 5 deg Trial

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage
Primary Device IDM69535141205050
NIH Device Record Key7d4d80a0-15cd-496d-8cc9-2d65aef354a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyber Medical
Version Model Number35-14120505
Catalog Number35-14120505
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)761-0933
Emailjstigliano@tybermed.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM69535141205050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M69535141205050]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-14

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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