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

CHANG HUA Changhua, TW

SYNTEC SCIENTIFIC CORP. appears in FDA device records in CHANG HUA Changhua, TW. FDA records list 19 510(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
19
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 19 510(k) clearances for Syntec Scientific Corp. between 1998 and 2021. The busiest year on record is 1998, with 4. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Syntec Scientific Corp., by decision year
YearClearances
19984
19994
20092
20101
20111
20121
20171
20192
20202
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K202790Syntec Orthodontic Mini Screw Extended SystemOATSubstantially Equivalent
K202935Syntec Femoral Nail Extended SystemHSBSubstantially Equivalent
K200933Syntec Non-Sterile Steinmann Pins SystemJDWSubstantially Equivalent
K191617Syntec Tibial Nail SystemHSBSubstantially Equivalent
K181296Syntec Femoral Nail SystemHSBSubstantially Equivalent
K161327SYNTEC HUMERAL NAIL SYSTEMHSBSubstantially Equivalent
K111189SYNTEC DENTAL IMPLANTDZESubstantially Equivalent
K101971SYNTEC OS SPINAL FIXATION SYSTEMNKBSubstantially Equivalent
K092889SYNTEC OSTEO-PLATE AND SCREW FIXATIONHRSSubstantially Equivalent
K090476SYNTEC ORTHODONTIC MINI SCREWOATSubstantially Equivalent
K090839MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTSHRSSubstantially Equivalent
K984602SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEMHSBSubstantially Equivalent
K984364SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820KTTSubstantially Equivalent
K984543SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25HSBSubstantially Equivalent
K983988SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATEHRSSubstantially Equivalent
K983873SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEMKTTSubstantially Equivalent
K983495SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420HWCSubstantially Equivalent
K983757SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01JDWSubstantially Equivalent
K983121NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220HTYSubstantially Equivalent

Registered establishments

FDA registered establishments for Syntec Scientific Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96169443003414678SYNTEC SCIENTIFIC CORP.2, KUNG SAN ROAD, CHUAN SHING, CHANG HUA Changhua 509 TW2026and 34 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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Data as of , FDA export datePage updated Source: openFDA, public domain