K-JAWS

Primary DI
03613720192206
Brand
K-JAWS
Company
MEDICREA INTERNATIONAL
Model
B10121512
Device description
ANTERIOR CERVICAL STABILIZATION H: 15mm x L: 12mm
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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PHQAnterior Staple As Supplemental Fixation For Fusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHQAnterior Staple As Supplemental Fixation For FusionOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133906000C-JAWS CERVICAL COMPRESSIVE STAPLEMedicrea International2014-07-24PHQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720192206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720192206036137201922063613720192206

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustableA non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
383228632
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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03613720286905UNiD OCTB33143500-01B33143500-012021-08-19
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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

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