4CIS SOLAR SPINE SYSTEM 4901-2007

GUDID 08806373525964

Persuader

SOLCO BIOMEDICAL CO.,LTD.

Orthopaedic implant inserter/extractor, reusable
Primary Device ID08806373525964
NIH Device Record Key0f2c880c-4562-4289-9721-3530df7c6792
Commercial Distribution StatusIn Commercial Distribution
Brand Name4CIS SOLAR SPINE SYSTEM
Version Model Number4901-2007
Catalog Number4901-2007
Company DUNS687844241
Company NameSOLCO BIOMEDICAL CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806373525964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806373525964]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-04-23
Device Publish Date2017-05-20

Devices Manufactured by SOLCO BIOMEDICAL CO.,LTD.

08806373595950 - 4CIS® INSTRUMENT SYSTEM2024-04-09 4CIS® Augusta Trial 323x36x26x10, 6degree
08806373595967 - 4CIS® INSTRUMENT SYSTEM2024-04-09 4CIS® Augusta Trial 323x36x26x12, 6degree
08806373595974 - 4CIS® INSTRUMENT SYSTEM2024-04-09 4CIS® Augusta Trial 323x36x26x14, 6degree
08806373595981 - 4CIS® INSTRUMENT SYSTEM2024-04-09 4CIS® Augusta Trial 323x36x26x16, 6degree
08806373595998 - 4CIS® INSTRUMENT SYSTEM2024-04-09 4CIS® Augusta Trial 323x36x26x18, 6degree
08806373596001 - 4CIS® INSTRUMENT SYSTEM2024-04-09 4CIS® Augusta Trial 323x36x26x20, 6degree
08806373596018 - 4CIS® INSTRUMENT SYSTEM2024-04-09 4CIS® Augusta Trial 323x36x26x12, 20degree
08806373596025 - 4CIS® INSTRUMENT SYSTEM2024-04-09 4CIS® Augusta Trial 323x36x26x14, 20degree

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