FDA.reportPublic FDA data

Regatta® Plate

Primary DI
10889981319908
Brand
Regatta® Plate
Company
Seaspine Orthopedics Corporation
Model
RP2-004000
Catalog number
RP2-004000
Device description
Offset Lateral Plate Inserter
Published
2024-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KQWGoniometer, nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQWGoniometer, NonpoweredOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200885000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200885000Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation2020-05-28KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981319908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998131990810889981319908

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079840876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981172374Mariner Outrigger99-000899-00082019-07-26
10889981172466Mariner Outrigger99-001799-00172019-07-26
10889981172695Mariner Outrigger99-1010-1299-1010-122019-07-30
10889981172732Mariner Outrigger99-1012-1299-1012-122019-07-30
10889981172749Mariner Outrigger99-1012-1499-1012-142019-07-30
10889981172800Mariner Outrigger99-1015-1499-1015-142019-07-30
10889981184940Mariner Outrigger99-1023-1299-1023-122019-07-30
10889981125783Newport MIS64-856564-85652025-12-19
10889981125790Newport MIS64-857064-85702025-12-19
10889981125837NewPort64-957064-95702024-12-11
10889981125844NewPort64-958064-95802024-12-11
10889981130060NewPort64-555064-55502024-12-11
10889981130077NewPort64-657564-65752024-12-11
10889981130091NewPort64-853064-85302024-12-11
10889981134921NewPort64-472564-47252024-12-11
10889981134938NewPort64-476064-47602024-12-11
10889981134945NewPort64-475564-47552024-12-11
10889981135348NewPort64-553064-55302024-12-11
10889981135355NewPort64-553564-55352024-12-11
10889981135362NewPort64-554064-55402024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024706842mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706859mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706866mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706873mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706880mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706897mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024694286mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024694316mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024694323mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024694330mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024680708mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
00889024680739mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
00889024680746mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
00889024680753mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
10889981319915Regatta® PlateSeaspine Orthopedics CorporationKQW2024-03-06
10889981319922Regatta® PlateSeaspine Orthopedics CorporationKQW2024-03-06
G586G95549410Novo SurgicalNOVO SURGICAL, INC.KQW2023-12-18
00087453152104JamarHYGENIC CORPORATION, THEKQW2023-12-07
10885914030445JamarHYGENIC CORPORATION, THEKQW2023-12-07
00887868581120mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00887868581151mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00887868581168mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00887868581175mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00816271020780myoRESEARCHNoraxon U.S.A., Inc.KQW2023-06-07
00860003118344CanarE – Clinic Wearable DeviceCanary Medical USA LLCKQW2023-05-17
00842962122624HNM MEDICALHNM STAINLESS, LLC.KQW2023-03-29
00887868574283mymobility® PlatformZimmer Us, Inc.KQW2023-03-16
00887868574290mymobility® PlatformZimmer Us, Inc.KQW2023-03-16
00887868574306mymobility® PlatformZimmer Us, Inc.KQW2023-03-16
00887868574313mymobility® PlatformZimmer Us, Inc.KQW2023-03-16