Tyber Medical 35-00000121

GUDID M69535000001210

ANTERIOR INSERTER 6"

Tyber Medical LLC

Polymeric osteotomy fusion cage Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized Polymeric osteotomy fusion cage, non-customized

• Primary Device ID: M69535000001210
• NIH Device Record Key: c784d1be-fc47-4167-8b0e-382fbfc4b9df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyber Medical
• Version Model Number: 35-00000121
• Catalog Number: 35-00000121
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M69535000001210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171327

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

[M69535000001210]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-11-14

On-Brand Devices [Tyber Medical]

• M695502P281508S1: PLIF 28mm x 8mm x 15mm x 0 °, TyPEEK, Sterile
• M695502P2615812S1: PLIF 26mm x 12mm x 15mm x 8 °, TyPEEK, Sterile
• M695302P301521S1: PLIF 30mm x 12mm x 15mm x 2 °, PEEK, Sterile
• M695302P22808S1: PLIF 22mm x 8mm x 8mm x 0 °, PEEK, Sterile
• M69535141205120: Cervical Curved 14 x 12 x 5 deg Trial
• M69535141205110: Cervical Curved 14 x 11 x 5 deg Trial
• M69535141205100: Cervical Curved 14 x 10 x 5 deg Trial
• M69535141205090: Cervical Curved 14 x 9 x 5 deg Trial
• M69535141205080: Cervical Curved 14 x 8 x 5 deg Trial
• M69535141205070: Cervical Curved 14 x 7 x 5 deg Trial
• M69535141205060: Cervical Curved 14 x 6 x 5 deg Trial
• M69535141205050: Cervical Curved 14 x 5 x 5 deg Trial
• M69535000001210: ANTERIOR INSERTER 6"
• M69525261015080: PLIF 26 x 15 x 8 deg Trial
• M69525261013080: PLIF 26 x 13 x 8 deg Trial
• M69525261012080: PLIF 26 x 12 x 8 deg Trial
• M69525261011080: PLIF 26 x 11 x 8 deg Trial
• M69525261010080: PLIF 26 x 10 x 8 ° Trial
• M69525261009080: PLIF 26 x 9 x 8 deg Trial
• M69525261008080: PLIF 26 x 8 x 8 deg Trial
• M69525261007080: PLIF 26 x 7 x 8 deg Trial
• M69525000000690: Offset Inserter 9"
• M69525000000090: 9" INSERTER
• M695002T3090020: TLIF Trial 30 x 10 x 9 x 0 deg
• M695002T3080020: TLIF Trial 30 x 10 x 8 x 0 deg
• M695002T3070020: TLIF Trial 30 x 10 x 7 x 0 deg
• M695002T30170020: TLIF 30 x 10 x 17x 0 DEG Trial
• M695002T30140020: TLIF Trial 30 x 10 x 14 x 0 deg
• M695002T30130020: TLIF Trial 30 x 10 x 13 x 0 deg
• M695002T30120020: TLIF Trial 30 x 10 x 12 x 0 deg
• M695002T30110020: TLIF Trial 30 x 10 x 11 x 0 deg
• M695002T30100020: TLIF Trial 30 x 10 x 10 x 0 deg
• M695002T2890040: TLIF 28 x 10 x 9 x 0° Trial
• M695002T2880040: TLIF 28 x 10 x 8 x 0° Trial
• M695002T28120040: TLIF 28 x 10 x 12 x 0° Trial
• M695002T28110040: TLIF 28 x 10 x 11 x 0° Trial
• M695002T28100040: TLIF 28 x 10 x 10 x 0° Trial
• M695002P329080: PLIF 32 x 9 x 0 deg Trial
• M695002P328080: PLIF 32 x 8 x 0 deg Trial
• M695002P327080: PLIF 32 x 7 x 0 deg Trial
• M695002P3214080: PLIF 32 x 14 x 0 deg Trial
• M695002P3213080: PLIF 32 x 13 x 0 deg Trial
• M695002P3212080: PLIF 32 x 12 x 0 deg Trial
• M695002P3211080: PLIF 32 x 11 x 0 deg Trial
• M695002P3210080: PLIF 32 x 10 x 0 deg Trial
• M695002P289080: PLIF 28 x 9 x 0 deg Trial
• M695002P288080: PLIF 28 x 8 x 0 deg Trial
• M695002P287080: PLIF 28 x 7 x 0 deg Trial
• M695002P269880: PLIF 26 x 9 x 8 ° Trial
• M695002P269480: 26 x 9 x 4 Degree Trial, 8mm Wide