Home / 510(k) Clearances / K895172

510(k) K895172

KRONNER SACRAL PIN GUIDE by Kronner Medical — Product Code LXH

K895172 is an FDA 510(k) premarket notification submitted by Kronner Medical for the device "KRONNER SACRAL PIN GUIDE". The FDA issued a decision of Substantially Equivalent on September 12, 1989. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Kronner Medical has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1989
Date Received
August 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Kronner Medical

  • K894228 — KRONNER SPHERICAL CUTTERS (July 23, 1990)
  • K895171 — BLOOD GAS SAFETY SYRINGE (November 7, 1989)
  • K895173 — SKELETAL FIXATION PIN (September 12, 1989)
  • K871248 — KRONNER COLLES-FOREARM EXTERNAL FIXATION (June 3, 1987)
  • K871249 — KRONNER BI-PLANER TIBIA EXTERNAL FIXATION (May 22, 1987)
  • K871247 — KRONNER UNIVERSAL FRAME EXTERNAL FIXATION (May 22, 1987)

Other clearances for product code LXH

  • K192873 — SX-One MicroKnife (December 20, 2019)
  • K140414 — IMBIBE NEEDLE (April 1, 2014)
  • K101609 — SELF RETAINING SOFT TISSUE RETRACTOR (December 9, 2010)
  • K001507 — MICROPERFORATION INSTRUMENT (June 14, 2000)
  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944188 — SPINAL MARKER (April 13, 1995)
  • K941896 — STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (November 7, 1994)
  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)

FDA data resources