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510(k) K100707

REPROCESSED PINS by Sterilmed, Inc. — Product Code NDM

K100707 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED PINS". The FDA issued a decision of Substantially Equivalent on June 25, 2010. The device falls under product code NDM (Pin, Fixation, Threaded, Metallic), a Class II device regulated under 21 CFR 888.3040. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2010
Date Received
March 12, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded, Metallic
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Sterilmed, Inc.

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  • K190478 — Reprocessed ViewFlex™ Xtra ICE Catheter (November 14, 2019)
  • K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (August 15, 2019)
  • K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (April 15, 2019)
  • K161700 — SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D D (November 21, 2016)
  • K161086 — Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed (September 20, 2016)
  • K153006 — Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) (June 23, 2016)
  • K152090 — Reprocessed Steerable Introducer (March 23, 2016)
  • K152134 — Reprocessed Vessel Sealer (January 15, 2016)
  • K150357 — Reprocessed Electrophysiology Diagnostic Catheters (August 27, 2015)

FDA data resources