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510(k) K161191

Latera Absorbable Nasal Implant by Spirox, Inc. — Product Code NHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2016
Date Received
April 27, 2016
Clearance Type
Special
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 Spirox, Inc.

  • K152958 — INEX Absorbable Nasal Implant (December 4, 2015)
  • K132920 — SPIROX INEX DEVICE (June 10, 2014)

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)
  • 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)
  • K092590 — PDS PLATES (February 17, 2010)