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510(k) K042606

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2005
Date Received
September 24, 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

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  • K082828 — SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (October 14, 2008)
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  • K041333 — SYNTHES (USA) TITANIUM WIRE (August 27, 2004)