FDA.reportPublic FDA data

Zuma-C™

Primary DI
10889981054021
Brand
Zuma-C™
Company
Seaspine Orthopedics Corporation
Model
57-8020
Catalog number
57-8020
Device description
Self-Drilling Variable Bone Screw, Single Lead, 4.0 x 20mm
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092521000ZUMA-CSeaspine, Inc.2010-04-13OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981054021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998105402110889981054021

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesis, non-sterileA non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)942-8698custsvcspine@seaspine.com

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
10889981172374Mariner Outrigger99-000899-00082019-07-26
10889981172466Mariner Outrigger99-001799-00172019-07-26
10889981172695Mariner Outrigger99-1010-1299-1010-122019-07-30
10889981172732Mariner Outrigger99-1012-1299-1012-122019-07-30
10889981172749Mariner Outrigger99-1012-1499-1012-142019-07-30
10889981172800Mariner Outrigger99-1015-1499-1015-142019-07-30
10889981184940Mariner Outrigger99-1023-1299-1023-122019-07-30
10889981125783Newport MIS64-856564-85652025-12-19
10889981125790Newport MIS64-857064-85702025-12-19
10889981125837NewPort64-957064-95702024-12-11
10889981125844NewPort64-958064-95802024-12-11
10889981130060NewPort64-555064-55502024-12-11
10889981130077NewPort64-657564-65752024-12-11
10889981130091NewPort64-853064-85302024-12-11
10889981134921NewPort64-472564-47252024-12-11
10889981134938NewPort64-476064-47602024-12-11
10889981134945NewPort64-475564-47552024-12-11
10889981135348NewPort64-553064-55302024-12-11
10889981135355NewPort64-553564-55352024-12-11
10889981135362NewPort64-554064-55402024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776391591CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391607CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391614CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391621CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391638CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391645CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391652CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391669CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391676CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391553CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-08
00810017916450Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916467Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916474Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.OVE2026-07-07
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00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
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