510(k) K041333

SYNTHES (USA) TITANIUM WIRE by Synthes (Usa) — Product Code GAQ

K041333 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES (USA) TITANIUM WIRE". The FDA issued a decision of Substantially Equivalent on August 27, 2004. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2004
Date Received
May 19, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type