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510(k) K770405

OVERLOAD WARNING DEVICE by Synthes (Usa) — Product Code IRN

K770405 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "OVERLOAD WARNING DEVICE". The FDA issued a decision of Substantially Equivalent on March 10, 1977. The device falls under product code IRN (Device, Warning, Overload, External Limb, Powered), a Class II device regulated under 21 CFR 890.5575. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1977
Date Received
March 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Warning, Overload, External Limb, Powered
Device Class
Class II
Regulation Number
890.5575
Review Panel
PM
Submission Type

Other clearances by Synthes (Usa)

  • K180821 — TruMatch Graft Cage - Long Bone (December 21, 2018)
  • K152239 — Zero-P Natural Plate System (December 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (March 31, 2014)
  • K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (May 20, 2013)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)

Other clearances for product code IRN

  • K060150 — SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM (February 23, 2006)
  • K023161 — SMARTSTEP SYSTEM (December 10, 2002)
  • K991313 — ACCUTRED SHOE (June 23, 1999)
  • K962591 — FOOT WEIGHT ALARM (December 4, 1996)
  • K960307 — INDEX SHOE (June 27, 1996)
  • K955034 — FORCEGUARD (April 10, 1996)
  • K950656 — PED ALERT (October 25, 1995)
  • K931517 — SAFE-STEP (March 10, 1995)
  • K882974 — FORCE GUARD I (November 4, 1988)
  • K792241 — PELIMIT (November 30, 1979)

FDA data resources