FDA.reportPublic FDA data

Cambria

Primary DI
10889981120542
Brand
Cambria
Company
Seaspine Orthopedics Corporation
Model
93-9208
Catalog number
93-9208
Device description
Cambria Trial, Large 15mm x 13mm x 8mm
Published
2018-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082309000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082309000CAMBRIASeaspine, Inc.2009-04-09ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981120542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998112054210889981120542

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

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(760)727-8399custsvcspine@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
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102289Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102296Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102302Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102319Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102326Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102364Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102371Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102388Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102395Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102401Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102418Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102425Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22