FDA.reportPublic FDA data

Cervical Interbody Fusion Device

Primary DI
B5651508L1
Brand
Cervical Interbody Fusion Device
Company
Maxim Surgical
Model
1508L
Catalog number
1508L
Device description
PEEK Cervical Spacer 15x13x8 mm Lordotic 6 degrees
Published
2017-07-21
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
K123206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123206000MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEMMaxim Surgical2013-02-07ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5651508L1PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle6degree
Height8Millimeter
Length15Millimeter
Width13Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9723315860xx@xx.xx

Regulatory Flags#

DUNS number
012241561
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B565CI10011Cervical Interbody Fusion DeviceCI1001CI10012017-07-21
B5651790400011Cervical Interbody Fusion Device179-040-001179-040-0012017-07-21
B5651790400021Cervical Interbody Fusion Device179-040-002179-040-0022017-07-21
B565MF2004C011Cervical Interbody Fusion DeviceMF2004c-01MF2004c-012017-07-21
B565CR1517051Cervical Interbody Fusion DeviceCR1517-05CR1517-052017-07-21
B565CR1517061Cervical Interbody Fusion DeviceCR1517-06CR1517-062017-07-21
B565CR1517071Cervical Interbody Fusion DeviceCR1517-07CR1517-072017-07-21
B565CR1517081Cervical Interbody Fusion DeviceCR1517-08CR1517-082017-07-21
B565CR1517091Cervical Interbody Fusion DeviceCR1517-09CR1517-092017-07-21
B565CR1517101Cervical Interbody Fusion DeviceCR1517-10CR1517-102017-07-21
B565CT150501Cervical Interbody Fusion DeviceCT1505-0CT1505-02017-07-21
B565CT150601Cervical Interbody Fusion DeviceCT1506-0CT1506-02017-07-21
B565CT15061Cervical Interbody Fusion DeviceCT1506CT15062017-07-21
B565CT150701Cervical Interbody Fusion DeviceCT1507-0CT1507-02017-07-21
B565CT15071Cervical Interbody Fusion DeviceCT1507CT15072017-07-21
B565CT150801Cervical Interbody Fusion DeviceCT1508-0CT1508-02017-07-21
B565CT15081Cervical Interbody Fusion DeviceCT1508CT15082017-07-21
B565CT150901Cervical Interbody Fusion DeviceCT1509-0CT1509-02017-07-21
B565CT15091Cervical Interbody Fusion DeviceCT1509CT15092017-07-21
B565CT151001Cervical Interbody Fusion DeviceCT1510-0CT1510-02017-07-21

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