CROSS-FUSE™* II PEEK VBR/IBF SYSTEM 38-1440-9-6L

GUDID 00846468007133

Crossfuse II Imp, 14x40x9, 6º lordosis

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468007133
• NIH Device Record Key: 9d1bcb91-127e-491d-84ee-b1340dff381a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CROSS-FUSE™* II PEEK VBR/IBF SYSTEM
• Version Model Number: 38-1440-9-6L
• Catalog Number: 38-1440-9-6L
• 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(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
• 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
• 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
• 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
• 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	00191083029894 [Primary]
GS1	00846468007133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623
• Premarket Notification: K170643

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-12-21

On-Brand Devices [CROSS-FUSE™* II PEEK VBR/IBF SYSTEM]

• 00846468062309: CROSSFUSE II CORONAL IMP 18x70x17 (6°C)
• 00846468062293: CROSSFUSE II CORONAL IMP 18x70x15 (6°C)
• 00846468062286: CROSSFUSE II CORONAL IMP 18x70x13 (6°C)
• 00846468062279: CROSSFUSE II CORONAL IMP 18x70x11 (6°C)
• 00846468062255: CROSSFUSE II CORONAL IMP 18x65x17 (6°C)
• 00846468062248: CROSSFUSE II CORONAL IMP 18x65x15 (6°C)
• 00846468062231: CROSSFUSE II CORONAL IMP 18x65x13 (6°C)
• 00846468062224: CROSSFUSE II CORONAL IMP 18x65x11 (6°C)
• 00846468062217: CROSSFUSE II CORONAL IMP 18x65x9 (6°C)
• 00846468062200: CROSSFUSE II CORONAL IMP 18x60x17 (6°C)
• 00846468062194: CROSSFUSE II CORONAL IMP 18x60x15 (6°C)
• 00846468062187: CROSSFUSE II CORONAL IMP 18x60x13 (6°C)
• 00846468062170: CROSSFUSE II CORONAL IMP 18x60x11 (6°C)
• 00846468062163: CROSSFUSE II CORONAL IMP 18x60x9 (6°C)
• 00846468062156: CROSSFUSE II CORONAL IMP 18x55x17 (6°C)
• 00846468062149: CROSSFUSE II CORONAL IMP 18x55x15 (6°C)
• 00846468062132: CROSSFUSE II CORONAL IMP 18x55x13 (6°C)
• 00846468062125: CROSSFUSE II CORONAL IMP 18x55x11 (6°C)
• 00846468062118: CROSSFUSE II CORONAL IMP 18x55x9 (6°C)
• 00846468062101: CROSSFUSE II CORONAL IMP 18x50x17 (6°C)
• 00846468062095: CROSSFUSE II CORONAL IMP 18x50x15 (6°C)
• 00846468062088: CROSSFUSE II CORONAL IMP 18x50x13 (6°C)
• 00846468062071: CROSSFUSE II CORONAL IMP 18x50x11 (6°C)
• 00846468062064: CROSSFUSE II CORONAL IMP 18x50x9 (6°C)
• 00846468062057: CROSSFUSE II CORONAL IMP 18x45x15 (6°C)
• 00846468062040: CROSSFUSE II CORONAL IMP 18x45x13 (6°C)
• 00846468062033: CROSSFUSE II CORONAL IMP 18x45x11 (6°C)
• 00846468062026: CROSSFUSE II CORONAL IMP 18x45x9 (6°C)
• 00846468062019: CROSSFUSE II CORONAL IMP 18x45x7 (6°C)
• 00846468062002: CROSSFUSE II CORONAL IMP 18x40x15 (6°C)
• 00846468061999: CROSSFUSE II CORONAL IMP 18x40x13 (6°C)
• 00846468061982: CROSSFUSE II CORONAL IMP 18x40x11 (6°C)
• 00846468061975: CROSSFUSE II CORONAL IMP 18x40x9 (6°C)
• 00846468061968: CROSSFUSE II CORONAL IMP 18x40x7 (6°C)
• 00846468059262: Crossfuse II Hyperlordic, 22x60x15 (12°)
• 00846468059255: Crossfuse II Hyperlordic, 22x60x13 (12°)
• 00846468059248: Crossfuse II Hyperlordic, 22x60x11 (12°)
• 00846468059224: Crossfuse II Hyperlordic, 22x55x15 (12°)
• 00846468059217: Crossfuse II Hyperlordic, 22x55x13 (12°)
• 00846468059200: Crossfuse II Hyperlordic, 22x55x11 (12°)
• 00846468059187: Crossfuse II Hyperlordic, 22x50x15 (12°)
• 00846468059170: Crossfuse II Hyperlordic, 22x50x13 (12°)
• 00846468059163: Crossfuse II Hyperlordic, 22x50x11 (12°)
• 00846468059156: Crossfuse II Hyperlordic, 22x45x15 (12°)
• 00846468059149: Crossfuse II Hyperlordic, 22x45x13 (12°)
• 00846468059132: Crossfuse II Hyperlordic, 22x45x11 (12°)
• 00846468058821: Crossfuse II Hyperlordic, 18x60x15 (12°)
• 00846468058814: Crossfuse II Hyperlordic, 18x60x13 (12°)
• 00846468058807: Crossfuse II Hyperlordic, 18x60x11 (12°)
• 00846468058791: Crossfuse II Hyperlordic, 18x60x9 (12°)