510(k) K983757

SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 by Syntec Scientific Corp. — Product Code JDW

K983757 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corp. for the device "SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01". The FDA issued a decision of Substantially Equivalent on Dec 4, 1998. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Syntec Scientific Corp. has 12 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 4, 1998
Date Received
Oct 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type
510(k)

Source: FDA 510(k) database entry for K983757. Report a data issue: hello@regdatalab.com.