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510(k) K153587

Taps for Resorbable Screws by Synthes (USA) Products, LLC — Product Code HBG

K153587 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "Taps for Resorbable Screws". The FDA issued a decision of Substantially Equivalent on January 18, 2017. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2017
Date Received
December 16, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Device Class
Class II
Regulation Number
882.4300
Review Panel
NE
Submission Type

Other clearances by Synthes (USA) Products, LLC

  • K254087 — MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (June 11, 2026)
  • K212943 — SyntheCel Dura Repair (January 28, 2022)
  • K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME) (May 25, 2021)
  • K210408 — DePuy Synthes Variable Angle Locking Patella Plating System (April 8, 2021)
  • K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Platin (March 26, 2021)
  • K201346 — DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Scr (September 23, 2020)
  • K192702 — DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (September 18, 2020)
  • K201944 — DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) (September 10, 2020)
  • K201578 — DePuy Synthes Variable Angle Locking Patella Plating System (September 9, 2020)
  • K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails (September 3, 2020)

Other clearances for product code HBG

  • K252696 — LEGACY (November 21, 2025)
  • K162884 — SpineGuard DSG Zavation Screw System (January 12, 2017)
  • K160129 — MRII Cranial Drill and Accessories (March 26, 2016)
  • K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (July 8, 2015)
  • K122456 — MRII CRAINIAL DRILL (March 22, 2013)
  • K022712 — HAND DRILL, MODEL 11-9901-7 (November 12, 2002)
  • K022370 — FRAMELOCK; FRAMELOCK ACCESSORIES (October 18, 2002)
  • K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILL (June 5, 1996)
  • K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILL (August 5, 1993)
  • K915546 — PS MEDICAL VENTRICULOSTOMY KIT (December 30, 1991)

FDA data resources