FDA.reportPublic FDA data

Regatta

Primary DI
10889981326814
Brand
Regatta
Company
Seaspine Orthopedics Corporation
Model
RP1-000316
Catalog number
RP1-000316
Device description
Plate Locking Cover, 16mm
Published
2025-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981326814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998132681410889981326814

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079840876
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981442187REEF LRL2-100608RL2-1006082026-06-19
10889981443344REEF LRL3-109002RL3-1090022026-06-19
10889981326234RegattaRP1-200200RP1-2002002025-01-17
10889981326777RegattaRP1-000308RP1-0003082025-01-17
10889981326784RegattaRP1-000310RP1-0003102025-01-17
10889981326791RegattaRP1-000312RP1-0003122025-01-17
10889981326807RegattaRP1-000314RP1-0003142025-01-17
10889981326821RegattaRP1-000318RP1-0003182025-01-17
10889981326838RegattaRP1-000320RP1-0003202025-01-17
10889981329969RegattaRP3-209300RP3-2093002025-01-17
10889981330002WaveForm LWL4-184015WL4-1840152025-01-17
10889981330026WaveForm LWL4-184515WL4-1845152025-01-17
10889981330040WaveForm LWL4-185015WL4-1850152025-01-17
10889981330064WaveForm LWL4-185515WL4-1855152025-01-17
10889981330088WaveForm LWL4-186015WL4-1860152025-01-17
10889981330101WaveForm LWL4-284015WL4-2840152025-01-17
10889981330125WaveForm LWL4-284515WL4-2845152025-01-17
10889981330149WaveForm LWL4-285015WL4-2850152025-01-17
10889981330163WaveForm LWL4-285515WL4-2855152025-01-17
10889981330187WaveForm LWL4-286015WL4-2860152025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809974809440Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809457Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809464Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809471Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809488Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809495Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809501Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809518Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809525Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809532Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809549Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809556Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809563Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809570Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809587Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809594Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809600Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809617Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809624Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809631Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809648Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809655Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809662Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974818879Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974836231Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974836286Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974837856Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974837955Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974839355Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974849590Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19