The Magnum Chin Implant
FDA 510(k) K961071 · Rand Scientific Corp.
510(k) numberK961071
Submission
- Device name
- The Magnum Chin Implant
- Applicant
- Rand Scientific Corp.
Sacramento, CA, US - Received
- March 18, 1996
- Decision date
- April 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FWP – Prosthesis, Chin, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…FWP · Traditional | Implantech Associates, Inc. | 07/10/2014SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | Howmedica Osteonics Corp. | 11/01/2012SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K963856 | Rand Nasal PackingEMX · Traditional | 10/18/1996SE |
| K961081 | Spirit Ridge Silicone Carving BlockMIB · Traditional | 05/22/1996SE |
| K961057 | Duralastic Sheeting IIMIB · Traditional | 05/16/1996SE |
| K955777 | Pmma ClasicHPX · Traditional | 05/16/1996SE |
| K961124 | The NautilusFZE · Traditional | 04/19/1996SE |
| K961080 | Medial Malar ImplantLZK · Traditional | 04/19/1996SE |
| K961072 | Pec ImplantMIC · Traditional | 04/19/1996SE |
| K955366 | Trans-Aire Rigid Gas Permable Contact LensHQD · Traditional | 03/28/1996SE |
| K952165 | Trans-Aire Rigid Gas Permeable Contact LensHQD · Traditional | 06/30/1995SE |
Questions and answers
When was The Magnum Chin Implant cleared by the FDA?
The Magnum Chin Implant (K961071) received a 510(k) decision of Substantially Equivalent on April 19, 1996, 32 days after the submission was received.
What is the product code of K961071?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.