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

Zhubei City Hsinchu, TW

WILTROM CORPORATION LIMITED appears in FDA device records in Zhubei City Hsinchu, TW. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. 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
5
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 5 510(k) clearances for Wiltrom Corporation Limited between 2012 and 2020. The busiest year on record is 2018, with 3. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Wiltrom Corporation Limited, by decision year
YearClearances
20121
20183
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K202894Wiltrom Spinal Fixation SystemNKBSubstantially Equivalent
K180758Osteocera Resorbable Bone SubstituteMQVSubstantially Equivalent
K172237Bicera Resorbable Bone SubstituteMQVSubstantially Equivalent
K172548Wiltrom Spinal Fixation SystemNKBSubstantially Equivalent
K110949BICERA (TM) RESORBABLE BONE SUBSTITUTEMQVSubstantially Equivalent

Registered establishments

FDA registered establishments for Wiltrom Corporation Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30119645773011964577WILTROM CORPORATION LIMITED1 F., No. 26, Sec. 2, Shengyi Rd., Zhubei City Hsinchu(County) 30261 TW2026
30143872943014387294WILTROM INC.2880 Zanker Road, Suite 103, San Jose, CA 95134 US2026

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