510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GS Medical Co., Ltd.

Heungdeok-gu, Cheongju-si Chungbuk, KR

GS MEDICAL CO., LTD. appears in FDA device records in Heungdeok-gu, Cheongju-si Chungbuk, KR. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for GS Medical Co., Ltd. between 2006 and 2024. The busiest year on record is 2023, with 3. The most recent is 2024, with 3.

Clearances by year, as a table
510(k) clearance decisions for GS Medical Co., Ltd., by decision year
YearClearances
20061
20102
20111
20141
20161
20171
20192
20201
20211
20221
20233
20243
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243073AnyPlus Navigated Instruments SystemOLOSubstantially Equivalent
K241738PYXIS 3D Titanium Cervical Cage systemODPSubstantially Equivalent
K240350AnyPlus II Spinal Fixation SystemNKBSubstantially Equivalent
K231808QUASAR Standalone ACIF SystemOVESubstantially Equivalent
K223868PYXIS 3D Titanium Cage SystemMAXSubstantially Equivalent
K222041CYGNUS-C Standalone ACIF SystemOVESubstantially Equivalent
K221687Pegasus-X Expandable PLIF SystemMAXSubstantially Equivalent
K211797TRACKER Plus Kyphoplasty SystemNDNSubstantially Equivalent
K200592GS Medical AnyPlus PEEK Cage SystemODPSubstantially Equivalent
K192335TRACKER Kyphoplasty SystemNDNSubstantially Equivalent
K190170MVP Cervical Plate SystemKWQSubstantially Equivalent
K172546AnyPlus® Spinal Fixation SystemNKBSubstantially Equivalent
K153517AnyPlus® Cervical PEEK Cage SystemODPSubstantially Equivalent
K131612ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGESMAXSubstantially Equivalent
K111354GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)MAXSubstantially Equivalent
K100516ANYPLUS PEEK CAGESOVDSubstantially Equivalent
K091717ANY PLUS SPINAL FIXATION SYSTEMNKBSubstantially Equivalent
K053573GSS PEDICLE SCREW SYSTEMMNHSubstantially Equivalent

Registered establishments

FDA registered establishments for GS Medical Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30055965143005596514GS MEDICAL CO., LTD.90, Osongsaengmyeong 4-ro, Osong-eup,, Heungdeok-gu, Cheongju-si Chungbuk 28161 KR2026and 29 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain