Straith Chin Implants
FDA 510(k) K801073 · Surgical Technology Laboratories, Inc.
510(k) numberK801073
Submission
- Device name
- Straith Chin Implants
- Applicant
- Surgical Technology Laboratories, Inc.
Mchenry, IL, US - Received
- May 6, 1980
- Decision date
- May 20, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254233 | MEDPOR Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 03/12/2026SE |
| K232593 | FITme Customized Silicone ImplantFWP · Traditional | Keosan Trading Co. | 11/22/2023SE |
| K200610 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 12/23/2020SE |
| K191130 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 08/23/2019SE |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 08/15/2019SE |
| K153508 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 02/05/2016SE |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantFWP · Traditional | Poriferous, LLC | 01/20/2016SE |
| K143173 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 03/23/2015SE |
| 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 |
More from Howmedica Osteonics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K170582 | Saf-T-Vac Smoke and Fluid EvacuatorGEI · Traditional | 04/14/2017SE |
| K021889 | Surgiform Augmentation Material (S.F.A.M.)KKY · Traditional | 10/16/2002SE |
| K983756 | Surgiform Anatomical MalarLZK · Special | 11/20/1998SE |
| K983755 | Nasal Dorsal SeriesFZE · Special | 11/20/1998SE |
| K983754 | Standard ChinFWP · Special | 11/20/1998SE |
| K964443 | Surgiform Anatomical MalarLZK · Traditional | 12/20/1996SE |
| K840835 | Straith Drain InserterFZX · Traditional | 04/23/1984SE |
| K831078 | Straith Oral AirwayCAE · Traditional | 06/24/1983SE |
| K801074 | Straith Nasal ImplantFZE · Traditional | 06/17/1980SE |
| K801072 | Straith Nasal SplintFYI · Traditional | 06/17/1980SE |
Questions and answers
When was Straith Chin Implants cleared by the FDA?
Straith Chin Implants (K801073) received a 510(k) decision of Substantially Equivalent on May 20, 1980, 14 days after the submission was received.
What is the product code of K801073?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.