Slimplicity® Self Drilling Screw Caddy Kit 61-BK-0204
GUDID 00840019936729
Slimplicity® Self Drilling Screw Caddy Kit
PRECISION SPINE, INC.
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00840019936729 |
| NIH Device Record Key | fc4ad17d-d784-483a-9b02-00f126786bf0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Slimplicity® Self Drilling Screw Caddy Kit |
| Version Model Number | 61-BK-0204 |
| Catalog Number | 61-BK-0204 |
| Company DUNS | 079398589 |
| Company Name | PRECISION SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840019936729 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060025
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
[00840019936729]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-06 |
| Device Publish Date | 2019-08-29 |
Devices Manufactured by PRECISION SPINE, INC.
| 00840019970969 - Reform Ti CT Modular MIS Pedicle Screw System | 2024-11-08 4.5 X 25mm Reform MC MIS Screw Assembly, Cannulated |
| 00840019971003 - Reform Ti CT Modular MIS Pedicle Screw System | 2024-11-08 K-Wire, NI Beveled |
| 00840019971577 - Reform Ti CT Modular MIS Pedicle Screw System | 2024-11-08 4.5 X 25mm Reform MC MIS Screw Assembly, Cannulated |
| 00840019971584 - Reform Ti CT Modular MIS Pedicle Screw System | 2024-11-08 4.5 X 30mm Reform MC MIS Screw Assembly, Cannulated |
| 00840019971591 - Reform Ti CT Modular MIS Pedicle Screw System | 2024-11-08 4.5 X 35mm Reform MC MIS Screw Assembly, Cannulated |
| 00840019971607 - Reform Ti CT Modular MIS Pedicle Screw System | 2024-11-08 4.5 X 40mm Reform MC MIS Screw Assembly, Cannulated |
| 00840019971614 - Reform Ti CT Modular MIS Pedicle Screw System | 2024-11-08 4.5 X 45mm Reform MC MIS Screw Assembly, Cannulated |
| 00840019971621 - Reform Ti CT Modular MIS Pedicle Screw System | 2024-11-08 5.0 X 25mm Reform MC MIS Screw Assembly, Cannulated |
Trademark Results [Slimplicity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SLIMPLICITY 77759488 3826256 Live/Registered |
Spanx, Inc. 2009-06-15 |
 SLIMPLICITY 77385608 3495633 Live/Registered |
Spinal USA 2008-01-31 |
 SLIMPLICITY 77061615 3279232 Dead/Cancelled |
Reliv' International, Inc. 2006-12-11 |
 SLIMPLICITY 75861405 not registered Dead/Abandoned |
Dale, Charles 1999-12-01 |
 SLIMPLICITY 72404773 0964554 Dead/Expired |
ENGLISH GRAINS LIMITED 1971-10-12 |
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