Modified Podiatry Products
FDA 510(k) K771006 · Dentronix, Inc.
510(k) numberK771006
Submission
- Device name
- Modified Podiatry Products
- Applicant
- Dentronix, Inc.
Mchenry, IL, US - Received
- June 2, 1977
- Decision date
- June 17, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTZ – Instrument, Cutting, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933933 | CeboplaneHTZ · Traditional | Synvasive Technology, Inc. | 04/15/1994SE |
| K931737 | Hedleyl Intramedullary Preparation BrushHTZ · Traditional | Synvasive Technology, Inc. | 01/07/1994SE |
| K870882 | 45 Degree ShaverHTZ · Traditional | Bowen & Company, Inc. | 03/23/1987SE |
| K853678 | Kambin Spinal Instrument SetHTZ · Traditional | Pilling Co. | 09/24/1985SE |
| K850527 | Arthroscopy Suction Biopsy PunchHTZ · Traditional | T. Korossurgical Instruments Corp. | 03/14/1985SE |
| K850423 | Concept Suction SleeveHTZ · Traditional | Concept, Inc. | 03/14/1985SE |
| K841980 | Side Cutting Serrated BladeHTZ · Traditional | Stainless Mfg., Inc. | 08/15/1984SE |
| K842774 | Codman Suction Punch-Product CodesHTZ · Traditional | Codman & Shurtleff, Inc. | 07/27/1984SE |
| K842111 | Kogan Endospeculum 9-1/2HTZ · Traditional | J. Sklar Mfg. Co., Inc. | 06/19/1984SE |
| K841982 | Meniscotome 4MM & 5MMHTZ · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
More from Stainless Mfg., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K910202 | Dentronix Model 2000KMH · Traditional | 03/13/1991SE |
| K880322 | Dentronix DDS 5000 Dry Heat Sterilization SystemKMH · Traditional | 07/13/1988SE |
| K771005 | New Podiatry ProductsHTZ · Traditional | 06/17/1977SE |
| K770305 | Cutter, P607 BoneFZT · Traditional | 03/09/1977SE |
| K770304 | Cutter, P605 General PurposeFZT · Traditional | 03/09/1977SE |
| K770303 | Nipper, Nail, P610 EnglishFZT · Traditional | 03/09/1977SE |
| K770302 | Cutter, P606 BoneFZT · Traditional | 03/09/1977SE |
| K770301 | Nipper, PSO4 TissueFZT · Traditional | 03/07/1977SE |
Questions and answers
When was Modified Podiatry Products cleared by the FDA?
Modified Podiatry Products (K771006) received a 510(k) decision of Substantially Equivalent on June 17, 1977, 15 days after the submission was received.
What is the product code of K771006?
The FDA product code is HTZ – Instrument, Cutting, Orthopedic, a Class I (low risk) device regulated under 21 CFR 878.4800.