Stabilis™
GUDID 00846832005376
TORNIER, INC.
Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable| Primary Device ID | 00846832005376 |
| NIH Device Record Key | df432300-3e01-49fd-b45c-13036fe0ff11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stabilis™ |
| Version Model Number | AFPSC4528 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 4.5 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832005376 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090139
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
Moist Heat or Steam Sterilization
[00846832005376]
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 | 2015-09-25 |
On-Brand Devices [Stabilis™]
| 00846832011414 | AFPCPTR |
| 00846832011407 | AFPCPLTR |
| 00846832011391 | AFPCPCR |
| 00846832011384 | AFPCPATR |
| 00846832005543 | AFPW |
| 00846832005536 | AFPTTL |
| 00846832005529 | AFPTTH |
| 00846832005499 | AFPTTC |
| 00846832005482 | AFPSC4565 |
| 00846832005475 | AFPSC4560 |
| 00846832005468 | AFPSC4555 |
| 00846832005451 | AFPSC4550 |
| 00846832005444 | AFPSC4545 |
| 00846832005437 | AFPSC4540 |
| 00846832005420 | AFPSC4538 |
| 00846832005413 | AFPSC4536 |
| 00846832005406 | AFPSC4534 |
| 00846832005390 | AFPSC4532 |
| 00846832005383 | AFPSC4530 |
| 00846832005376 | AFPSC4528 |
| 00846832005369 | AFPSC4526 |
| 00846832005352 | AFPSC4524 |
| 00846832005345 | AFPSC4522 |
| 00846832005338 | AFPSC4520 |
| 00846832005321 | AFPSC4518 |
| 00846832005314 | AFPSC4516 |
| 00846832005307 | AFPSC4514 |
| 00846832005000 | AFPCPT |
| 00846832004997 | AFPCPLT |
| 00846832004980 | AFPCPC |
| 00846832004973 | AFPCPAT |
| 00846832004935 | AFPAUG |
| 00846832004928 | AFPATTL |
| 00846832004911 | AFPATTH |
Trademark Results [Stabilis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STABILIS 98456259 not registered Live/Pending |
Acuity Surgical Devices, LLC 2024-03-19 |
 STABILIS 97859337 not registered Live/Pending |
Wilbur-Ellis Company LLC 2023-03-27 |
 STABILIS 97834824 not registered Live/Pending |
LF BOLT CORP. 2023-03-12 |
 STABILIS 88201393 5947550 Live/Registered |
Stabilis Energy, LLC 2018-11-20 |
 STABILIS 88124005 not registered Live/Pending |
Hunter and Son Construction, Inc. 2018-09-19 |
 STABILIS 87572531 not registered Dead/Abandoned |
Stabilis Pro, LLC 2017-08-17 |
 STABILIS 86656836 5519905 Live/Registered |
THE BOARD OF REGENTS FOR OKLAHOMA STATEUNIVERSITY 2015-06-09 |
 STABILIS 86032957 4650046 Live/Registered |
Peerless Industriies, Inc. 2013-08-08 |
 STABILIS 85515548 4411688 Live/Registered |
Stabilis Capital Management, LP 2012-01-12 |
 STABILIS 85363916 4124807 Live/Registered |
The Prophet Corporation 2011-07-06 |
 STABILIS 76174966 not registered Dead/Abandoned |
STRYKER SPINE SA 2000-11-27 |
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