FDA.reportPublic FDA data

Cervical Interbody Fusion Device

Primary DI
B565MF2004C011
Brand
Cervical Interbody Fusion Device
Company
Maxim Surgical
Model
MF2004c-01
Catalog number
MF2004c-01
Device description
Sterilization Tray
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
B565MF2004C011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems and sterilizers; it is not dedicated to sterilization. This device may or may not be fitted with a lid or cover. This is a reusable device.

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
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
B565CT15101Cervical Interbody Fusion DeviceCT1510CT15102017-07-21

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