FDA.reportPublic FDA data

Regatta

Primary DI
10889981285111
Brand
Regatta
Company
Seaspine Orthopedics Corporation
Model
RP1-105540
Catalog number
RP1-105540
Device description
Variable Angle Screw, 5.5mm Dia. x 40mm
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

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
10889981285111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998128511110889981285111

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
00810017916245SABER-XA, Expandable Spacer, 40x30mm, 11mm, (6°)ELEVATION SPINE, INC.KWQ2026-10-07
00810017916252SABER-XA, Expandable Spacer, 40x30mm, 13mm, (12°)ELEVATION SPINE, INC.KWQ2026-10-07
00810017916269SABER-XA, Expandable Spacer, 40x30mm, 16mm, (18°)ELEVATION SPINE, INC.KWQ2026-10-07
00810228161687corraCarlsmed, Inc.KWQ2026-10-05
00810228161694corraCarlsmed, Inc.KWQ2026-10-05
00810228161700corraCarlsmed, Inc.KWQ2026-10-05
00810228161717corraCarlsmed, Inc.KWQ2026-10-05
00810228161724corraCarlsmed, Inc.KWQ2026-10-05
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.KWQ2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.KWQ2026-10-01
10888857598256Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598416Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598423Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598430Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598447Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24