510(k) K132920
K132920 is an FDA 510(k) premarket notification submitted by Spirox, Inc. for the device "SPIROX INEX DEVICE". The FDA issued a decision of Substantially Equivalent on June 10, 2014. The device falls under product code NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable), a Class II device regulated under 21 CFR 874.3620. Spirox, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2014
- Date Received
- September 17, 2013
- 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.