Home / 510(k) Clearances / K052405

510(k) K052405

STERLING INTERFERENC SCREW HT by Regeneration Technologies, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2005
Date Received
September 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Regeneration Technologies, Inc.

  • K080418 — REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIP (April 30, 2008)
  • K072238 — BIOSET XCH (January 25, 2008)
  • K072327 — CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON (October 24, 2007)
  • K063584 — STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID (May 9, 2007)
  • K060180 — BIOSET XC (September 6, 2006)
  • K060253 — STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. (February 23, 2006)
  • K051615 — STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES (August 15, 2005)
  • K050767 — STERLING INTERFERENCE SCREW ST (June 9, 2005)
  • K043421 — OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC (February 16, 2005)
  • K043420 — OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE (February 10, 2005)

Other clearances for product code HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)
  • K251382 — Phoenix Sinus Tarsi Stent System (August 27, 2025)
  • K250867 — Dunamis Screw and Suture Locking System (August 15, 2025)
  • K250251 — Eleganz Fusion Screw System (Fusion Screw System) (June 13, 2025)