Rexious HOOK

Primary DI
08809319787044
Brand
Rexious HOOK
Company
DIOMEDICAL CO.,LTD.
Model
A
Catalog number
RX.LH.1504
Device description
Long Arm Laminar Hook W5 X H4mm
Published
2017-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113324000REXIOUS HOOK FIXATION SYSTEMSDio Medical Co., Ltd.2012-03-28KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809319787044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809319787044088093197870448809319787044

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82313699470info@diomedical.com

Regulatory Flags#

DUNS number
557795909
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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08800039830133Fortis ACPATPA.PL.03522019-07-19
08800039830140Fortis ACPATPA.PL.03552019-07-19
08800039830157Fortis ACPATPA.PL.03582019-07-19
08800039830188Fortis ACPATPA.PL.01222019-07-19

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