Home / 510(k) Clearances / K792253

510(k) K792253

ARICULATED TENSION DEVICE SYNTHES TEN by Synthes (Usa) — Product Code HWN

K792253 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "ARICULATED TENSION DEVICE SYNTHES TEN". The FDA issued a decision of Substantially Equivalent on December 5, 1979. The device falls under product code HWN (Instrument, Compression), a Class I device regulated under 21 CFR 888.4540. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1979
Date Received
November 7, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Compression
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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 HWN

  • K854241 — AOT EXTERNAL COMPRESS DEVICE (March 3, 1986)
  • K770349 — RIGID TEACHING ATTACHMENT (March 7, 1977)
  • K760970 — FLORIO CPC BAND (November 23, 1976)

FDA data resources