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510(k) K060198

MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW by Linvatec Corp. — Product Code HRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2006
Date Received
January 26, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Arthroscope
Device Class
Class II
Regulation Number
888.1100
Review Panel
OR
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Linvatec Corp.

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  • K090835 — CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR (June 22, 2009)
  • K090186 — CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES (April 10, 2009)
  • K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL (February 25, 2009)
  • K060270 — MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL (April 10, 2006)
  • K060260 — MICROPOWER HAND PIECE HIGH SPEED DRILL (April 10, 2006)
  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K050497 — BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET (March 25, 2005)
  • K050227 — THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER (March 2, 2005)

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  • K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (October 15, 2025)
  • K252594 — UltraGuideCTR® image guided soft tissue release system (September 29, 2025)
  • K243774 — ELID (Endoscopic Less Invasive Decompression) System (August 27, 2025)
  • K241990 — SpineSite Endoscope System (July 30, 2025)
  • K243602 — Arthrex Spine Endoscope (May 16, 2025)