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510(k) K051488

MEDICINELODGE ZIPKNOT by Medicinelodge, Inc. — Product Code NVH

K051488 is an FDA 510(k) premarket notification submitted by Medicinelodge, Inc. for the device "MEDICINELODGE ZIPKNOT". The FDA issued a decision of Substantially Equivalent on July 27, 2005. The device falls under product code NVH (Suture, Knot, Mechanical), a Class II device regulated under 21 CFR 878.4300. Medicinelodge, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2005
Date Received
June 6, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Knot, Mechanical
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

In approximation and/or ligation of soft tissue

Other clearances by Medicinelodge, Inc.

  • K072525 — ZIPKNOT, MODEL 1017-3000 (October 5, 2007)
  • K962705 — MLI MODULAR STAPLE (October 1, 1996)
  • K961920 — CROSS PIN (September 17, 1996)
  • K961905 — MEDICINELODGE, INC. SET SCREW (August 6, 1996)
  • K962194 — MLI SOFT TISSUE SCREW & WASHER SYSTEM (July 30, 1996)
  • K961025 — EXPANDED BODY SUTURE (April 15, 1996)
  • K953350 — MLI INTERFERENCE SCREW (January 30, 1996)

FDA data resources