FDA.reportPublic FDA data

Regatta® Plate

Primary DI
10889981319922
Brand
Regatta® Plate
Company
Seaspine Orthopedics Corporation
Model
RP2-004003
Catalog number
RP2-004003
Device description
Plate Inserter Wrench
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
10889981319922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998131992210889981319922

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. 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
10889981206116BoneSyncABS-3202ABS-32022019-10-10
10889981206123BoneSyncABS-3205ABS-32052019-10-10
10889981206130BoneSyncABS-3210ABS-32102019-10-10
10889981206147BoneSyncABS-3215ABS-32152019-10-10
10889981206154BoneSyncABS-3310ABS-33102019-10-10
10889981206161BoneSyncABS-3315ABS-33152019-10-10
10889981308933Cove02-9200-01302-9200-0132023-10-30
10889981308940Cove02-9200-02502-9200-0252023-10-30
10889981308957Cove02-9200-05002-9200-0502023-10-30
10889981308964Cove02-9200-10002-9200-1002023-10-30
10889981308971Cove02-9300-05002-9300-0502023-10-30
10889981308988Cove02-9300-10002-9300-1002023-10-30
10889981308995Cove02-9300-15002-9300-1502023-10-30
10889981309008Cove02-9300-30002-9300-3002023-10-30
10889981309022OsteoCove56920013569200132023-10-30
10889981309039OsteoCove56920025569200252023-10-30
10889981309046OsteoCove56920050569200502023-10-30
10889981309053OsteoCove56920100569201002023-10-30
10889981309060OsteoCove56930050569300502023-10-30
10889981309077OsteoCove56930100569301002023-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850015699184Canary Medical Gait ParametersCanary Medical USA LLCKQW2026-10-08
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
10889981319908Regatta® PlateSeaspine Orthopedics CorporationKQW2024-03-06
10889981319915Regatta® 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