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

GOYANG-SI Gyeonggi, KR

ACE MEDICAL appears in FDA device records in GOYANG-SI Gyeonggi, KR. FDA records list 22 510(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
22
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 22 510(k) clearances for Ace Medical between 1987 and 2020. The busiest year on record is 1991, with 5. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ace Medical, by decision year
YearClearances
19873
19881
19891
19902
19915
19931
19942
19953
19962
19971
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200387Ace Medical Surgical InstrumentsHAESubstantially Equivalent
K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILHSBSubstantially Equivalent
K955472ACE HUMERUS & RADIUS PLATESHRSSubstantially Equivalent
K955388ACE-DUPONT COMPOSITE RINGSLXTSubstantially Equivalent
K9544856.5MM SOLID CANCELLOUS BONE SCREWHWCSubstantially Equivalent
K954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSHAXSubstantially Equivalent
K950618ACE SUPRACONDYLAR PLATEHRSSubstantially Equivalent
K933968ACE PELVIC STABILIZERJECSubstantially Equivalent
K931652ACE 6.5 MM BONE SCREWHWCSubstantially Equivalent for Some Indications
K930592ACE UNIVERSAL RECONSTRUCTION PLATEHRSSubstantially Equivalent
K912598ACE CORTICAL BONE SCREWHWCSubstantially Equivalent for Some Indications
K914858ACE OPEN-BACK HALO RINGJECSubstantially Equivalent
K911554AIM TIBIAL NAILHSBSubstantially Equivalent
K905595ACE RECONSTRUCTIVE PLATEHRSSubstantially Equivalent
K905048ACE 3.5MM CORTICAL BONE SCREWHWCSubstantially Equivalent
K903811ACE CANNULATED CORTICAL BONE SCREWHWCSubstantially Equivalent for Some Indications
K903810ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREWHWCSubstantially Equivalent for Some Indications
K892214REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREWHWCSubstantially Equivalent
K873684ACE INTRA COMPARTMENTAL PRESSURE MONITORLXCSubstantially Equivalent
K874593ACE SELFTAPPING CANCELLOUS BONE SCREWHWCSubstantially Equivalent
K872858WILLIAMS VERTEBRAL SPREADERHXPSubstantially Equivalent
K872859ACE CANCELLOUS BONE SCREWHWCSubstantially Equivalent

Registered establishments

FDA registered establishments for Ace Medical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30051267043005126704ACE MEDICAL33, NAEYOO-ROAD 124, GOYANG-SI Gyeonggi 10264 KR2026

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