Implantech Midface-Submalar Le Fort Implant
FDA 510(k) K942420 · King & Spalding
510(k) numberK942420
Submission
- Device name
- Implantech Midface-Submalar Le Fort Implant
- Applicant
- King & Spalding
Washington, DC, US - Received
- May 20, 1994
- Decision date
- August 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LZK – Implant, Malar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code LZK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021419 | Aart Malar ImplantLZK · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K002886 | Implantech Composite Facial Implants (Malar, Chin, and Nasal)LZK · Traditional | Implantech Associates, Inc. | 11/24/2000SE |
| K992240 | Pillar Malar ImplantLZK · Traditional | Pillar Surgical, Inc. | 11/22/1999SE |
| K983756 | Surgiform Anatomical MalarLZK · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982763 | Seare Biomedical Malar ImplantsLZK · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
| K981835 | Silimed Malar ImplantLZK · Traditional | Silimed, LLC | 07/09/1998SE |
| K980141 | Spectrum Designs Projection Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980140 | Spectrum Designs Medial Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980139 | Spectrum Designs Profile Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K973502 | Implantech Conform Binder Submalar ImplantLZK · Traditional | Implantech Associates, Inc. | 11/07/1997SE |
More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942423 | Nais Wrist Blood Pressure MeterDXN · Traditional | 02/15/1995SE |
| K942422 | Panasonic Wrist Blood Pressure MeterDXN · Traditional | 02/15/1995SE |
| K945998 | Chin Implant Style IFWP · Traditional | 02/07/1995SE |
| K944408 | Implantech Medical Grade Silicone SheetingMIB · Traditional | 11/09/1994SE |
| K942421 | Implantech Lateral Mandibular Bar ImplantLZK · Traditional | 08/08/1994SE |
| K941972 | Hemo-O-LokFZP · Traditional | 06/29/1994SE |
Questions and answers
When was Implantech Midface-Submalar Le Fort Implant cleared by the FDA?
Implantech Midface-Submalar Le Fort Implant (K942420) received a 510(k) decision of Substantially Equivalent on August 8, 1994, 80 days after the submission was received.
What is the product code of K942420?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.