FDA.reportPublic FDA data

Regatta

Primary DI
10889981285173
Brand
Regatta
Company
Seaspine Orthopedics Corporation
Model
RP1-106035
Catalog number
RP1-106035
Device description
Variable Angle Screw, 6.0mm Dia. x 35mm
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
10889981285173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998128517310889981285173

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
10889981080877Malibu91-214791-21472016-05-02
10889981125820Newport Complex MIS64-956564-95652026-03-03
10889981125851Newport Complex MIS64-959064-95902026-03-03
10889981130084Newport Complex MIS64-750564-75052026-03-03
10889981135331Newport Complex MIS64-552564-55252026-03-03
10889981135386Newport Complex MIS64-555564-55552026-03-03
10889981135393Newport Complex MIS64-556064-55602026-03-03
10889981135522Newport Complex MIS64-655064-65502026-03-03
10889981135553Newport Complex MIS64-656564-65652026-03-03
10889981135584Newport Complex MIS64-658564-65852026-03-03
10889981135591Newport Complex MIS64-659064-65902026-03-03
10889981135867Newport Complex MIS64-754564-75452026-03-03
10889981135997Newport Complex MIS64-851064-85102026-03-03
10889981136017Newport Complex MIS64-858564-85852026-03-03
10889981136079Newport Complex MIS64-957564-95752026-03-03
10889981136086Newport Complex MIS64-958564-95852026-03-03
10889981145668NewPort™65-474565-47452026-03-03
10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311248360Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248421Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248438Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248445Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248452Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248513Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840493422398RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422404RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422411RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422428RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422435RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422442RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422459RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422466RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422473RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422480RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422497RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422503RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422510RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422527RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422589RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02