FDA.reportPublic FDA data

Meridian

Primary DI
10889981214487
Brand
Meridian
Company
Seaspine Orthopedics Corporation
Model
RA1-006035
Catalog number
RA1-006035
Device description
Fixed Angle Screw, 6.0mm Dia. x 35mm
Published
2020-12-30
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

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981214487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998121448710889981214487

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

Contacts#

Phone, Email table
PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

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
10889981326814RegattaRP1-000316RP1-0003162025-01-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810236520001ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520018ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520025ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520032ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520049ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520056ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520063ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520070ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520087ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520094ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520100ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520117ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520124ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520131ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520148ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520155ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520162ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520179ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520186ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520193ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520209ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520216ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520223ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520230ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520247ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520254ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520261ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520278ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520285ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520292ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10