Specials SR-0396-02
GUDID 10889981192150
Regatta Angled Inserter, 40° x 0°
SEASPINE ORTHOPEDICS CORPORATION
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 10889981192150 |
| NIH Device Record Key | f49c2753-ae28-48c8-ad5a-a0741a8b60a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Specials |
| Version Model Number | SR-0396-02 |
| Catalog Number | SR-0396-02 |
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981192150 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181079
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
[10889981192150]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
On-Brand Devices [Specials]
| 10889994170480 | Rod Rocker |
| 10889987170749 | Double Barrel Drill Guide |
| 10889987170732 | Angled Cobb |
| 10889987170411 | Offset Clip |
| 10889987170398 | 4mm Driver |
| 10889987170336 | Large Dilator |
| 10889987170329 | Locking Medium Dilator |
| 10889987170312 | Locking Set Screw Inserter |
| 10889987164847 | Lamina Spreader |
| 10889987164830 | 6.0mm Coronal Benders, Right |
| 10889987164823 | 6.0mm Coronal Benders, Left |
| 10889987164816 | 6.0mm Benders, Right |
| 10889987164809 | 6.0mm Benders, Left |
| 10889987164724 | Mariner tab breaker for Malibu |
| 10889987164533 | ALIF Parallel Distractor |
| 10889987164434 | Split Tip Hex Driver, 4mm |
| 10889987164427 | Screw Seat Adjuster |
| 10889987164410 | Mariner extended turn key 2 |
| 10889987164403 | Mariner extended turn key 1 |
| 10889987163574 | Trial w/o stop 16x14x12mm, 7 Deg |
| 10889987163567 | Trial w/o stop 16x14x11mm, 7 Deg |
| 10889987163550 | Trial w/o stop 16x14x10mm, 7 Deg |
| 10889987163543 | Trial w/o stop 16x14x09mm, 7 Deg |
| 10889987163536 | Trial w/o stop 16x14x08mm, 7 Deg |
| 10889987163529 | Trial w/o stop 16x14x07mm, 7 Deg |
| 10889987163512 | Trial w/o stop 16x14x06mm, 7 Deg |
| 10889987163505 | Trial w/o stop 16x14x05mm, 7 Deg |
| 10889987163369 | T-Handled Malibu Straight Probe |
| 10889987163314 | Bridge Caliper 6.0 |
| 10889987163161 | 30° Angled, Rotated 90° Teardop Curette, 6mm |
| 10889987163154 | 45° Angled Teardop Curette, 6mm |
| 10889987163147 | Straight Teardop Curette, 6mm |
| 10889985163088 | Locking Screw Inserter Sleeve |
| 10889984163072 | Single Action Persuader |
| 10889982163050 | Syringe Tip Pusher |
| 10889981257163 | Crossbar Counter Torque |
| 10889981256982 | Dilator 5, Threaded |
| 10889981256975 | Dilator 4, Threaded |
| 10889981256968 | Dilator 3, Threaded |
| 10889981256951 | Dilator 2, Threaded |
| 10889981256357 | Coronal Bender Ø3.5mm/4.0mm, Right |
| 10889981256340 | Coronal Bender Ø3.5mm/4.0mm, Left |
| 10889981255961 | Solid Tap, Tri-Flat, 9.50mm |
| 10889981255954 | Solid Tap, Tri-Flat, 8.50mm |
| 10889981255947 | Solid Tap, Tri-Flat, 7.50mm |
| 10889981255930 | Solid Tap, Tri-Flat, 6.50mm |
| 10889981255923 | Solid Tap, Tri-Flat, 5.50mm |
| 10889981255916 | Solid Tap, Tri-Flat, 4.50mm |
| 10889981255909 | Pedicle Screw Driver, Locking, Tri-Flat |
| 10889981255893 | Set Screw Starter, Tri-Flat |
Trademark Results [Specials]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPECIALS 77339815 not registered Dead/Abandoned |
Lambeth, Kiernan 2007-11-29 |
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