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510(k) K002790

ADD-ON CONDYLE by Walter Lorenz Surgical, Inc. — Product Code NEI

K002790 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "ADD-ON CONDYLE". The FDA issued a decision of Substantially Equivalent on August 6, 2001. The device falls under product code NEI (Prosthesis, Condyle, Mandibular, Temporary), a Class II device regulated under 21 CFR 872.4770. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2001
Date Received
September 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Condyle, Mandibular, Temporary
Device Class
Class II
Regulation Number
872.4770
Review Panel
DE
Submission Type

Other clearances by Walter Lorenz Surgical, Inc.

  • K063386 — LORENZ ORTHODONTIC ANCHORAGE SYSTEM (February 9, 2007)
  • K063052 — LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES (January 12, 2007)
  • K063506 — LORENZ STERNAL CLOSURE SYSTEM (December 18, 2006)
  • K062842 — TWIST DRILL (December 4, 2006)
  • K061384 — LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITAN (June 6, 2006)
  • K042516 — OTOMIMIX (November 8, 2004)
  • K030425 — LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER (May 14, 2004)
  • K040990 — MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS (May 13, 2004)
  • K040983 — LORENZ SELF-DRILLING IMF SCREW (May 5, 2004)
  • K033740 — LORENZ STERNAL CLOSURE SYSTEM (December 15, 2003)

Other clearances for product code NEI

  • K133285 — STRYKER TEMPORARY CONDYLAR PROSTHESIS (April 9, 2014)
  • K081747 — MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (September 5, 2008)
  • K063181 — SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (January 5, 2007)
  • K031701 — OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM (July 8, 2004)
  • K990667 — KLS-MARTIN TEMPORARY CONDYLAR IMPLANT (July 27, 2001)
  • K990637 — SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD (October 22, 1999)

FDA data resources