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510(k) K012320

POWERPRO BATTERY SYSTEM by Linvatec Corp. — Product Code HAB

K012320 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "POWERPRO BATTERY SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 19, 2001. The device falls under product code HAB (Saw, Powered, And Accessories), a Class I device regulated under 21 CFR 878.4820. Linvatec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 19, 2001
Date Received
Jul 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saw, Powered, And Accessories
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Linvatec Corp.

  • K092998 — CONMED LINVATEC INTERCEPT IMPLANT (Dec 23, 2009)
  • K091549 — CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM (Jun 23, 2009)
  • K090835 — CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR (Jun 22, 2009)
  • K090186 — CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES (Apr 10, 2009)
  • K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL (Feb 25, 2009)
  • K060198 — MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND (May 11, 2006)
  • K060270 — MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL (Apr 10, 2006)
  • K060260 — MICROPOWER HAND PIECE HIGH SPEED DRILL (Apr 10, 2006)
  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K050497 — BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET (Mar 25, 2005)

Other clearances for product code HAB

  • K935517 — SNAP STERNUM SAW (Mar 10, 1994)

FDA data resources