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510(k) K012409

LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS by Walter Lorenz Surgical, Inc. — Product Code NHB

K012409 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS". The FDA issued a decision of Substantially Equivalent on October 18, 2001. The device falls under product code NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable), a Class II device regulated under 21 CFR 874.3620. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2001
Date Received
July 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.

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 NHB

  • K251790 — SeptAlign (January 16, 2026)
  • K233569 — SeptAlign (March 22, 2024)
  • K223167 — Spirair Nasal Septal Strap (August 17, 2023)
  • K210411 — PosiSep EAR Fragmentable Ear Dressing (May 5, 2022)
  • K192661 — LATERA Absorbable Nasal Implant System (November 10, 2019)
  • K183015 — PuraSinus (April 12, 2019)
  • K161191 — Latera Absorbable Nasal Implant (June 23, 2016)
  • K152958 — INEX Absorbable Nasal Implant (December 4, 2015)
  • K132920 — SPIROX INEX DEVICE (June 10, 2014)
  • K122434 — MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL (October 31, 2012)

FDA data resources