SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM 21-116-S
GUDID 00846468024987
SlimFuse Asm, Std, 1 Level, 16mm
Pioneer Surgical Technology, Inc.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00846468024987 |
| NIH Device Record Key | f0593edc-9ef6-4cd6-b34a-961eb74e86d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM |
| Version Model Number | 21-116-S |
| Catalog Number | 21-116-S |
| 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 | |
| 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(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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468024987 [Primary] |
| GS1 | 00846468092191 [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 |
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
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[00846468024987]
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[00846468024987]
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[00846468024987]
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[00846468024987]
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[00846468024987]
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[00846468024987]
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[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
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[00846468024987]
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[00846468024987]
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[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
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[00846468024987]
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[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
[00846468024987]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-12-08 |
On-Brand Devices [SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM]
| 00846468025663 | 5.0 x 16 SELF-TAPPING RESCUE SCREW |
| 00846468025656 | 5.0 x 14 SELF-TAPPING RESCUE SCREW |
| 00846468025649 | 5.0 x 12 SELF-TAPPING RESCUE SCREW |
| 00846468025564 | 4.5 x 20 SELF-TAPPING SCREW, SLIMFUSE |
| 00846468025540 | 4.5 x 18 SELF-TAPPING SCREW, SLIMFUSE |
| 00846468025526 | 4.5 x 16 SELF-TAPPING SCREW, SLIMFUSE |
| 00846468025502 | 4.5 x 14 SELF-TAPPING SCREW, SLIMFUSE |
| 00846468025489 | 4.5 x 12 SELF-TAPPING SCREW, SLIMFUSE |
| 00846468025427 | 4.5 x 16 SELF-DRILLING SCREW, SLIMFUSE |
| 00846468025403 | 4.5 x 14 SELF-DRILLING SCREW, SLIMFUSE |
| 00846468025380 | 4.5 x 12 SELF-DRILLING SCREW, SLIMFUSE |
| 00846468025366 | 4.5 x 16 SELF-TAPPING RESCUE SCREW |
| 00846468025342 | 4.5 x 14 SELF-TAPPING RESCUE SCREW |
| 00846468025328 | 4.5 x 12 SELF-TAPPING RESCUE SCREW |
| 00846468025229 | SlimFuse Asm, Std, 2 Level, 44mm |
| 00846468025212 | SlimFuse Asm, Dyn, 2 Level, 44mm |
| 00846468025205 | SlimFuse Asm, Std, 2 Level, 41mm |
| 00846468025199 | SlimFuse Asm, Dyn, 2 Level, 41mm |
| 00846468025182 | SlimFuse Asm, Std, 2 Level, 38mm |
| 00846468025175 | SlimFuse Asm, Dyn, 2 Level, 38mm |
| 00846468025168 | SlimFuse Asm, Std, 2 Level, 35mm |
| 00846468025151 | SlimFuse Asm, Dyn, 2 Level, 35mm |
| 00846468025144 | SlimFuse Asm, Std, 2 Level, 32mm |
| 00846468025137 | SlimFuse Asm, Dyn, 2 Level, 32mm |
| 00846468025120 | SlimFuse Asm, Std, 2 Level, 29mm |
| 00846468025113 | SlimFuse Asm, Dyn, 2 Level, 29mm |
| 00846468025106 | SlimFuse Asm, Std, 2 Level, 27mm |
| 00846468025090 | SlimFuse Asm, Dyn, 2 Level, 27mm |
| 00846468025083 | SlimFuse Asm, Std, 1 Level, 26mm |
| 00846468025076 | SlimFuse Asm, Dyn, 1 Level, 26mm |
| 00846468025069 | SlimFuse Asm, Std, 1 Level, 24mm |
| 00846468025052 | SlimFuse Asm, Dyn, 1 Level, 24mm |
| 00846468025045 | SlimFuse Asm, Std, 1 Level, 22mm |
| 00846468025038 | SlimFuse Asm, Dyn, 1 Level, 22mm |
| 00846468025021 | SlimFuse Asm, Std, 1 Level, 20mm |
| 00846468025014 | SlimFuse Asm, Dyn, 1 Level, 20mm |
| 00846468025007 | SlimFuse Asm, Std, 1 Level, 18mm |
| 00846468024994 | SlimFuse Asm, Dyn, 1 Level, 18mm |
| 00846468024987 | SlimFuse Asm, Std, 1 Level, 16mm |
| 00846468024970 | SlimFuse Asm, Dyn, 1 Level, 16mm |
| 00846468024963 | SlimFuse Asm, Std, 1 Level, 14mm |
| 00846468024956 | SlimFuse Asm, Dyn, 1 Level, 14mm |
| 00846468024949 | SlimFuse Asm, Std, 1 Level, 12mm |
| 00846468024932 | SlimFuse Asm, Dyn, 1 Level, 12mm |
| 00846468024925 | SlimFuse Asm, Std, 1 Level, 10mm |
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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