FDA.reportPublic FDA data

Cervical Interbody Fusion Device

Primary DI
B565FP20011
Brand
Cervical Interbody Fusion Device
Company
Maxim Surgical
Model
FP2001
Catalog number
FP2001
Device description
Final Positioner
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
B565FP20011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tampA hand-held, surgical instrument used to pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of high-grade stainless steel, but some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure or by tapping the proximal end with a hammer/mallet. 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
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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Primary DI, Brand, Company table
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