FDA.reportPublic FDA data

IMPIX MANTA

Primary DI
03613720230717
Brand
IMPIX MANTA
Company
MEDICREA INTERNATIONAL
Model
B20121773
Catalog number
B20121773
Device description
IMPIX-MANTA 17x14x7mm at 3°
Published
2015-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K100484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100484000IMPIX MANTA CERVICAL INTERBODY DEVICEMedicrea2010-03-16ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720230717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720230717036137202307173613720230717

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
383228632
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03613720249832PASS TLA220302002017-01-31
03613720286875UNiD OCTB33243600-01B33243600-012021-08-19
03613720286882UNiD OCTB33243500-01B33243500-012021-08-19
03613720286899UNiD OCTB33143600-01B33143600-012021-08-19
03613720286905UNiD OCTB33143500-01B33143500-012021-08-19
03613720286936UNiD RODB33136012-01B33136012-012021-08-19
03613720286943UNiD RODB33236012-01B33236012-012021-08-19
03613720268451UNiD RODB33125512-01B33125512-012017-06-12
03613720268468UNiD RODB33125512-02B33125512-022017-06-12
03613720268628UNiD RODB33225512-01B33225512-012017-06-12
03613720268635UNiD RODB33225512-02B33225512-022017-06-12
03613720268963UNiD RODB33126012-01B33126012-012017-08-28
03613720268970UNiD RODB33126012-02B33126012-022017-08-28
03613720269137UNiD RODB33226012-01B33226012-012017-08-28
03613720269144UNiD RODB33226012-02B33226012-022017-08-28
03613720269304UNiD OCTB33123500-01B33123500-012017-09-12
03613720269311UNiD OCTB33123500-02B33123500-022017-09-12
03613720269397UNiD OCTB33223500-01B33223500-012017-09-12
03613720269403UNiD OCTB33223500-02B33223500-022017-09-12
03613720286585UNiD MISB33155522-01B33155522-012021-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640221370471SCARLET® AC-TiSpineArt SAODP2025-11-10
07640164849645icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2025-06-02
07640164849652icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2025-06-02
07640164849669icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2025-06-02
07640164849676icotec Cervical Cage, Cervical Cage Anatomic, Container Rackicotec AGODP2025-06-02
07640332477991SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478004SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478011SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332477984SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478684SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478691SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478707SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478714SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478721SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478738SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478745SCARLET® AC-TiSpineArt SAODP2024-08-02
07640172551400icotec Cervical Cage, Inserter Sleeve, longicotec AGODP2021-09-01
07640172551417icotec Cervical Cage, Inserter Rod, longicotec AGODP2021-09-01
07640185341760SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341784SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341807SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341746SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-07
07640140433363icotec Lumbar Cage, Slotted Hammericotec AGODP2018-07-16
07640140433783icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2018-07-16
07640140433790icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2018-07-16
07640140433806icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2018-07-16
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07640140433820icotec Cervical Cage, Anatomic Probe, 6 mm x 13 mmicotec AGODP2018-07-16