BULLET-TIP PEEK IBF SYSTEM 32-17-22

GUDID 00846468090807

INTERBODY FUSION DEVICE

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468090807
• NIH Device Record Key: bd7f46bf-54eb-4648-af51-b0771eed8541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BULLET-TIP PEEK IBF SYSTEM
• Version Model Number: 32-17-22
• Catalog Number: 32-17-22
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468090807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133455

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [BULLET-TIP PEEK IBF SYSTEM]

• 00846468086664: INSERTER MODULAR CLEANING
• 00846468077945: INSTRUMENT CASE
• 00846468074746: INSTRUMENT CASE
• 00846468066789: SHORT, INLINE HANDLE, HUDSON
• 00846468066772: 32mm, TRIAL CADDY
• 00846468066765: 26mm, TRIAL CADDY
• 00846468066758: 22mm, TRIAL CADDY
• 00846468066543: 26MM, Lordotic Detachable Trial Caddy
• 00846468066536: 22mm, Lordotic Detachable Trial Caddy
• 00846468066161: TRIAL SPACER
• 00846468066154: TRIAL SPACER
• 00846468066147: TRIAL SPACER
• 00846468066130: TRIAL SPACER
• 00846468066116: TRIAL SPACER
• 00846468066109: TRIAL SPACER
• 00846468066093: TRIAL SPACER
• 00846468066086: TRIAL SPACER
• 00846468066079: TRIAL SPACER
• 00846468066062: TRIAL SPACER
• 00846468066055: TRIAL SPACER
• 00846468066048: TRIAL SPACER
• 00846468066031: TRIAL SPACER
• 00846468066024: TRIAL SPACER
• 00846468066017: TRIAL SPACER
• 00846468066000: TRIAL SPACER
• 00846468065997: TRIAL SPACER
• 00846468065980: TRIAL SPACER
• 00846468065973: TRIAL SPACER
• 00846468054557: INSERTER
• 00846468054540: DETACHABLE TRIAL SPACER
• 00846468054533: DETACHABLE TRIAL SPACER
• 00846468054526: DETACHABLE TRIAL SPACER
• 00846468054519: DETACHABLE TRIAL SPACER
• 00846468054502: DETACHABLE TRIAL SPACER
• 00846468054496: DETACHABLE TRIAL SPACER
• 00846468054489: DETACHABLE TRIAL SPACER
• 00846468054472: DETACHABLE TRIAL SPACER
• 00846468054465: DETACHABLE TRIAL SPACER
• 00846468054458: DETACHABLE TRIAL SPACER
• 00846468054441: DETACHABLE TRIAL SPACER
• 00846468054434: DETACHABLE TRIAL SPACER
• 00846468054427: DETACHABLE TRIAL SPACER
• 00846468054410: DETACHABLE TRIAL SPACER
• 00846468054403: DETACHABLE TRIAL SPACER
• 00846468054397: DETACHABLE TRIAL SPACER
• 00846468054380: DETACHABLE TRIAL SPACER
• 00846468054373: DETACHABLE TRIAL SPACER
• 00846468054366: DETACHABLE TRIAL SPACER
• 00846468054359: DETACHABLE TRIAL SPACER
• 00846468054342: LOLLIPOP TRIAL SPACER