Lorenz Lactosorb Vocal Medialization Implant
FDA 510(k) K011554 · Biomet, Inc.
510(k) numberK011554
Submission
- Device name
- Lorenz Lactosorb Vocal Medialization Implant
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- May 18, 2001
- Decision date
- June 26, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MIX – System, Vocal Cord Medialization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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|---|---|---|---|
| K240919 | Silk Voice (SMI-04)MIX · Special | Sofregen Medical | 05/03/2024SE |
| K180631 | Silk VoiceMIX · Traditional | Sofregen Medical, Inc. | 11/08/2018SE |
| K150400 | Renu GelMIX · Special | Cytophil, Inc. | 04/06/2015SE |
| K121795 | Calcium Hydroxylapatite Vocal Fold ImplantMIX · Traditional | Cytophil, Inc. | 02/22/2013SE |
| K083783 | VF LiquigelMIX · Traditional | Coapt Systems, Inc. | 09/11/2009SE |
| K081816 | Vocalis and Vocalis SMMIX · Traditional | Cytophil, Inc. | 01/05/2009SE |
| K081815 | Vocalis GelMIX · Traditional | Cytophil, Inc. | 01/05/2009SE |
| K080956 | Modification to VF Gel PlusMIX · Special | Coapt Systems, Inc. | 04/25/2008SE |
| K071663 | VF Gel PlusMIX · Traditional | Coapt Systems, Inc. | 02/15/2008SE |
| K070090 | Radiesse Laryngeal ImplantMIX · Special | Bioform Medical, Inc. | 03/01/2007SE |
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Questions and answers
When was Lorenz Lactosorb Vocal Medialization Implant cleared by the FDA?
Lorenz Lactosorb Vocal Medialization Implant (K011554) received a 510(k) decision of Substantially Equivalent on June 26, 2001, 39 days after the submission was received.
What is the product code of K011554?
The FDA product code is MIX – System, Vocal Cord Medialization, a Class II (moderate risk) device regulated under 21 CFR 874.3620.