Stainless Steel 25-12-4525
GUDID 10889981022204
Polyaxial Screw, 4.75mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10889981022204 |
| NIH Device Record Key | e86f674a-0039-4011-80db-9848299618be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stainless Steel |
| Version Model Number | 25-12-4525 |
| Catalog Number | 25-12-4525 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| 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 | false |
| 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(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981022204 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100970
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
Moist Heat or Steam Sterilization
[10889981022204]
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 | 2015-09-24 |
On-Brand Devices [Stainless Steel]
| 10889981140090 | Stainless Locking Screws Instruments |
| 10889981114893 | Cross Connector Sterilization Case |
| 10889981114886 | Locking Screw Sterilization Case |
| 10889981114879 | Rod Sterilization Case |
| 10889981114862 | Hook Sterilization Case |
| 10889981114855 | Sterilization Case, Deformity Pedicle Screws |
| 10889981114848 | Poly Screw Sterilization Case |
| 10889981114831 | Fixed Screw Sterilization Case |
| 10889981114824 | Pedicle Prep Sterilization Case |
| 10889981114817 | T-25 Screw Driver |
| 10889981114800 | Rotation Block |
| 10889981114794 | Gearteeth Coronal Rod Bender, Right |
| 10889981114787 | Gearteeth Coronal Rod Bender, Left |
| 10889981114770 | Sagittal Deformity Rod Bender, Right |
| 10889981114763 | Sagittal Deformity Rod Bender, Left |
| 10889981114756 | Rod Guided Hook Impactor |
| 10889981114749 | Offset Hook/Screw Holder |
| 10889981114732 | In-Line Hook/Screw Holder |
| 10889981114725 | Hook Impactor |
| 10889981114718 | Double Action Rod Gripper |
| 10889981114701 | Rod Pusher |
| 10889981114695 | Cross Connector Gage |
| 10889981114688 | Cross Connector Bender |
| 10889981114671 | Cross Connector Cam Driver |
| 10889981114664 | Rod / Cross Connector Holder |
| 10889981114640 | Screw Sizing Block |
| 10889981114633 | Rocker |
| 10889981114626 | Locking Screw Inserter - T-Handle |
| 10889981114619 | Kerrison Persuader |
| 10889981114602 | Locking Screw Final Driver |
| 10889981114596 | Counter Torque Instrument |
| 10889981114589 | Fixed Screw/Hook Inserter |
| 10889981114572 | Locking Screw Guide Tube |
| 10889981114565 | Polyaxial Screw Inserter (Standard) |
| 10889981114558 | Polyaxial Screw Inserter (Q style) |
| 10889981114541 | T-25 Screw Driver, T-Handle |
| 10889981114534 | Screw Seat Adjuster |
| 10889981114527 | T-40 Screw Driver, T-Handle |
| 10889981114510 | Locking Screw Inserter |
| 10889981114503 | Torque Limiting Handle - 125 in.-lb. |
| 10889981114046 | Malleable Rod, 400mm |
| 10889981028800 | Fixed Cross Connector, 60mm. The Stainless Steel Spinal System consists of a variety of types an |
| 10889981028794 | Fixed Cross Connector, 56mm. The Stainless Steel Spinal System consists of a variety of types an |
| 10889981028787 | Fixed Cross Connector, 52mm. The Stainless Steel Spinal System consists of a variety of types an |
| 10889981028770 | Fixed Cross Connector, 48mm. The Stainless Steel Spinal System consists of a variety of types an |
| 10889981028763 | Fixed Cross Connector, 44mm. The Stainless Steel Spinal System consists of a variety of types an |
| 10889981028756 | Fixed Cross Connector, 40mm. The Stainless Steel Spinal System consists of a variety of types an |
| 10889981028749 | Fixed Cross Connector, 38mm. The Stainless Steel Spinal System consists of a variety of types an |
| 10889981028732 | Fixed Cross Connector, 36mm. The Stainless Steel Spinal System consists of a variety of types an |
| 10889981028725 | Fixed Cross Connector, 34mm. The Stainless Steel Spinal System consists of a variety of types an |
Trademark Results [Stainless Steel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STAINLESS STEEL 98024489 not registered Live/Pending |
Allwo LLC 2023-06-02 |
 STAINLESS STEEL 75234363 2177543 Live/Registered |
Absecon Mills, Inc. 1997-01-31 |
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