FDA.reportPublic FDA data

COMET Lumbar Interbody Fusion Cage

Primary DI
04710577041486
Brand
COMET Lumbar Interbody Fusion Cage
Company
BAUI BIOTECH CO. LTD.
Model
595-11318
Device description
PEEK Interbody Fusion Cage
Published
2020-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191353000COMET Lumbar Interbody Fusion CageBaui Biotech Co., Ltd.2020-04-14MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710577041486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710577041486047105770414864710577041486

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656775504
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04718251502254Facilis™ Spinal System156-1216*2025-01-09
04719883860842NOVA Minimally Invasive System156-12162025-01-09
04710577040144Facilis™ Spinal System156-12162020-02-14
04710577040939Orthopedic manual surgical instrument409-0813B2025-01-15
04710577040953Orthopedic manual surgical instrument405-11032025-01-15
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04710577041691Orthopedic manual surgical instrument409-0829B2025-01-15
04710577043282Orthopedic manual surgical instrument405-0801B2025-01-15
04710577043374Orthopedic manual surgical instrument409-0901B2025-01-15
04710577043381Orthopedic manual surgical instrument409-14052025-01-15
04710577043398Orthopedic manual surgical instrument409-14042025-01-15
04710577043404Orthopedic manual surgical instrument409-14032025-01-15
04710577043473Orthopedic manual surgical instrument409-0829F2025-01-15
04710577043503Orthopedic manual surgical instrument406-0103D2025-01-15
04710577043510Orthopedic manual surgical instrument409-0836B2025-01-15
04710577043558Orthopedic manual surgical instrument405-0502A2025-01-15
04710577043619Orthopedic manual surgical instrument405-0904J2025-01-15
04710577044616Orthopedic manual surgical instrument406-0504B2025-01-15
04712899253110Orthopedic manual surgical instrument406-01072025-01-15
04712899253158Orthopedic manual surgical instrument406-01032025-01-15

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