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510(k) K962194

MLI SOFT TISSUE SCREW & WASHER SYSTEM by Medicinelodge, Inc. — Product Code MBI

K962194 is an FDA 510(k) premarket notification submitted by Medicinelodge, Inc. for the device "MLI SOFT TISSUE SCREW & WASHER SYSTEM". The FDA issued a decision of Substantially Equivalent on July 30, 1996. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Medicinelodge, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1996
Date Received
June 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Medicinelodge, Inc.

  • K072525 — ZIPKNOT, MODEL 1017-3000 (October 5, 2007)
  • K051488 — MEDICINELODGE ZIPKNOT (July 27, 2005)
  • K962705 — MLI MODULAR STAPLE (October 1, 1996)
  • K961920 — CROSS PIN (September 17, 1996)
  • K961905 — MEDICINELODGE, INC. SET SCREW (August 6, 1996)
  • K961025 — EXPANDED BODY SUTURE (April 15, 1996)
  • K953350 — MLI INTERFERENCE SCREW (January 30, 1996)

Other clearances for product code MBI

  • K260018 — Arthrex FiberButton (June 26, 2026)
  • K253130 — Dione PEEK Screw System (May 27, 2026)
  • K261363 — Y-Knotless™ Flex Anchors (May 13, 2026)
  • K253027 — Anchor with Fiber Wire and Disposable Inserter (May 6, 2026)
  • K252635 — ArthroTAK Tendon Anchor Kit (May 1, 2026)
  • K260921 — Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (April 21, 2026)
  • K260561 — Arthrex FiberTak Suture Anchor (March 20, 2026)
  • K253886 — Grappler Suture Anchor PCFD Tether System (March 17, 2026)
  • K254176 — SINEFIX (March 16, 2026)
  • K251750 — Trax EX Anchor (March 12, 2026)

FDA data resources