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510(k) K013775

TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM by Stryker Leibinger — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2002
Date Received
November 13, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Stryker Leibinger

  • K133974 — VARIAX DISTAL RADIUS PLATING SYSTEM (March 24, 2014)
  • K052871 — STRYKER CUSTOM TI IMPLANT (December 16, 2005)
  • K043250 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT (April 15, 2005)
  • K041651 — STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM (September 30, 2004)
  • K040022 — STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM (March 12, 2004)
  • K022579 — STRYKER NAVIGATION SYSTEM-KNEE MODULE (June 2, 2003)
  • K023449 — NON-INVASIVE PATIENT FIXATION SYSTEM (January 13, 2003)
  • K012380 — MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL F (December 3, 2001)
  • K000594 — LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE (December 8, 2000)
  • K000348 — COLORADO MICRODISSECTION NEEDLE (May 3, 2000)

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  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
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