CROSS-FUSE™* II PEEK VBR/IBF SYSTEM 38-1855-15-6L
GUDID 00846468008208
Crossfuse II Imp, 18x55x15, 6º lordosis
Pioneer Surgical Technology, Inc.
Vertebral body prosthesis| Primary Device ID | 00846468008208 |
| NIH Device Record Key | 693cdd27-a268-43ff-8984-faa80bc94ee1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CROSS-FUSE™* II PEEK VBR/IBF SYSTEM |
| Version Model Number | 38-1855-15-6L |
| Catalog Number | 38-1855-15-6L |
| 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 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com | |
| Phone | +1(906)226-9909 |
| labeling@resolvesurg.com |
Device Dimensions
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083030586 [Primary] |
| GS1 | 00846468008208 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
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°) |
Trademark Results [CROSS-FUSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CROSS-FUSE 77284786 3544634 Live/Registered |
Pioneer Surgical Technology, Inc. 2007-09-20 |
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