Regatta
The SeaSpine Regatta Lateral System is an intervertebral fusion device with a large central graft window. The FDA filing describes it alongside Meridian and distinguishes the lateral…
The SeaSpine Regatta Lateral System is an intervertebral fusion device with a large central graft window. The FDA filing describes it alongside Meridian and distinguishes the lateral interbody configuration from a separate TruProfile plate assembly.
Regatta lateral interbody implants are intended for use with supplemental fixation. A different TruProfile configuration assembled with a lateral plate and screws is described for standalone use. These configurations have different support conditions and should be kept distinct.
Listed Item
Lateral Implant, 18mm x 16mm x 55mm, 10 Deg
Materials and Configuration
The systems use PEEK interbodies with radiographic markers and a thin commercially pure titanium surface coat. Regatta implants require supplemental fixation; the distinct TruProfile assembly has separate stated use conditions.
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K200879 |
| Record published | 2021-02-02 |
| Record revised | 2025-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RP1-100114 | In distribution | |
| 36-180855-00 | In distribution | |
| 36-181650-00 | In distribution | |
| 36-181655-10 | In distribution | |
| 36-181040-15 | In distribution | |
| 36-181640-00 | In distribution | |
| RP1-002218 | In distribution | |
| 36-181655-00 | In distribution | |
| RP1-002214 | In distribution | |
| 36-181460-10 | In distribution | |
| 36-181260-00 | In distribution | |
| RP1-100108 | In distribution | |
| RP1-100116 | In distribution | |
| RP1-002208 | In distribution | |
| 36-181640-10 | In distribution | |
| 36-181060-00 | In distribution | |
| RP3-109010 | In distribution | |
| 36-181240-15 | In distribution | |
| RP1-000318 | In distribution | |
| 36-181645-00 | In distribution | |
| RP1-105555 | In distribution | |
| RP1-002216 | In distribution | |
| 36-181460-00 | In distribution | |
| RP3-109200 | In distribution | |
| 36-181650-10 | In distribution | |
| 36-181660-15 | In distribution | |
| RP3-109001 | In distribution | |
| 36-180860-00 | In distribution | |
| RP1-000308 | In distribution | |
| RP1-002220 | In distribution | |
| 36-181455-00 | In distribution | |
| 36-181660-10 | In distribution | |
| 36-181440-15 | In distribution | |
| RP3-209300 | In distribution | |
| 36-181460-15 | In distribution | |
| 36-181255-00 | In distribution | |
| 36-181645-10 | In distribution | |
| 36-181660-00 | In distribution | |
| 36-181055-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253420 | 2026-07-01 |
| K241466 | 2024-06-20 |
| K240566 | 2024-04-26 |
| K233694 | 2024-01-12 |
| K222732 | 2022-11-07 |
| K220711 | 2022-05-10 |
| K213420 | 2022-05-04 |
| K212540 | 2021-09-10 |
| K210497 | 2021-07-07 |
| K210583 | 2021-06-02 |
| K201755 | 2020-12-15 |
| K201193 | 2020-11-25 |
| K200879 | 2020-06-10 |
| K193636 | 2020-04-24 |
| K193418 | 2020-03-13 |
| K192132 | 2019-12-03 |
| K181079 | 2018-07-18 |
| K173260 | 2017-12-04 |
| K173022 | 2017-10-26 |
| K162715 | 2016-10-28 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-08-06 | Class II | Device Design | Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may r | 74 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.