Slimfuse® Anterior Cervical Plate System 21-45-SD-18T
GUDID 00846468025441
SELF-DRILLING SCREW
Pioneer Surgical Technology, Inc.
Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00846468025441 |
| NIH Device Record Key | f07c0940-8c9b-4023-a1f3-c95f4e2fd67f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Slimfuse® Anterior Cervical Plate System |
| Version Model Number | 21-45-SD-18T |
| Catalog Number | 21-45-SD-18T |
| 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 | 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(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468025441 [Primary] |
| GS1 | 00846468092535 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072703
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
[00846468025441]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-06 |
| Device Publish Date | 2018-10-06 |
Devices Manufactured by Pioneer Surgical Technology, Inc.
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| 00840298702534 - CODA™ Anterior Cervical Plate System | 2024-02-19 Variable Self Tapping Screw |
| 00840298700349 - CODA™ Anterior Cervical Plate System | 2023-12-13 Constrained Self Tapping Screw |
| 00840298700356 - CODA™ Anterior Cervical Plate System | 2023-12-13 Constrained Self Tapping Screw |
| 00840298700363 - CODA™ Anterior Cervical Plate System | 2023-12-13 Constrained Self Tapping Screw |
| 00840298700370 - CODA™ Anterior Cervical Plate System | 2023-12-13 Constrained Self Tapping Screw |
| 00840298700387 - CODA™ Anterior Cervical Plate System | 2023-12-13 Constrained Self Tapping Screw |
| 00840298700394 - CODA™ Anterior Cervical Plate System | 2023-12-13 Constrained Self Tapping Screw |
Trademark Results [Slimfuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SLIMFUSE 77282637 3581301 Live/Registered |
Pioneer Surgical Technology, Inc. 2007-09-18 |
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