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

Uijeongbu-si Gyeonggi, KR

CG MedTech Co., Ltd. appears in FDA device records in Uijeongbu-si Gyeonggi, KR. FDA records list 37 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
37
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to CG MedTech Co., Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • U&I Corporation510(k), enforcement report, recall

510(k) clearance history

FDA records hold 37 510(k) clearances for CG MedTech Co., Ltd. between 2005 and 2025. The busiest year on record is 2018, with 6. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for CG MedTech Co., Ltd., by decision year
YearClearances
20052
20061
20092
20102
20122
20133
20144
20153
20161
20174
20186
20193
20211
20221
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252351UniSpace® TPLIF CageMAXSubstantially Equivalent
K251725ANAX™ OCT Spinal SystemNKGSubstantially Equivalent
K220147Aspiron S ACP SystemKWQSubstantially Equivalent
K210573Velofix SA Cervical CageOVESubstantially Equivalent
K183243Velofix TLIF CageMAXSubstantially Equivalent
K190067Velofix Interbody Fusion SystemODPSubstantially Equivalent
K190053SECULOK™ ACP SystemKWQSubstantially Equivalent
K181824CBT Screw Fixation SystemNKBSubstantially Equivalent
K183383ANAX™ OCT Spinal SystemNKGSubstantially Equivalent
K181829Velofix TLIF CageMAXSubstantially Equivalent
K182055SECULOK™ ACP SystemKWQSubstantially Equivalent
K180759SECULOK™ Suture AnchorMBISubstantially Equivalent
K173198Facet Screw Fixation SystemMRWSubstantially Equivalent
K173524ANAX 5.5™ Spinal SystemNKBSubstantially Equivalent
K172419Velofix™ TLIF CageMAXSubstantially Equivalent
K172424Velofix™ SA Cervical CageOVESubstantially Equivalent
K171749Velofix(tm) Interbody Fusion SystemODPSubstantially Equivalent
K162189ANAX™ 5.5 Spinal SystemMNHSubstantially Equivalent
K143631Benefix Interspinous Fixation SystemPEKSubstantially Equivalent
K150570ANAX OCT Spinal SystemNKGSubstantially Equivalent
K143417ANAX 5.5 Spinal SystemMNHSubstantially Equivalent
K132797L'DISQGEISubstantially Equivalent
K140864VELOXTM INTERBODY FUSION SYSTEMODPSubstantially Equivalent
K140234ASPIRON ACP SYSTEMKWQSubstantially Equivalent
K132926VELOFIXTM INTERBODY FUSION SYSTEMODPSubstantially Equivalent
K132218PERFIX ILIAC SCREW SYSTEMMNHSubstantially Equivalent
K132101ANAX 5.5 SPINAL SYSTEMMNHSubstantially Equivalent
K131200ASPIRON ACP SYSTEMKWQSubstantially Equivalent
K120419DYNA LOCKING ANKLE NAILHSBSubstantially Equivalent
K112240DYNA LOCKING CANNULATED SCREWHWCSubstantially Equivalent
K102367OPTIGEN TOTAL KNEE SYSTEMJWHSubstantially Equivalent
K093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820HSBSubstantially Equivalent
K092771DYNA LOCKING IM NAILHSBSubstantially Equivalent
K091725PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)MNHSubstantially Equivalent
K061002MAXIMA ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent
K051971OPTIMA SPINAL SYSTEMKWQSubstantially Equivalent
K042928MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEMMNHSubstantially Equivalent

Registered establishments

FDA registered establishments for CG MedTech Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96172973003200961CG MedTech Co., Ltd.20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si Gyeonggi 11781 KR2026and 28 more, listed in full below

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2672-2020ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM6.0x50mm poly-reduction screws were laser etched 6.0x45Class IITerminated
Z-1823-2020Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.Class IITerminated

Verification record

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