Drilling Template
FDA 510(k) K853761 · Orthopedic Systems, Inc.
510(k) numberK853761
Submission
- Device name
- Drilling Template
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- September 9, 1985
- Decision date
- October 7, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K971782 | Bone and Marrow Collection System KitGEY · Traditional | Biomedical Ent., Inc. | 07/29/1997SE |
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| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
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| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
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Questions and answers
When was Drilling Template cleared by the FDA?
Drilling Template (K853761) received a 510(k) decision of Substantially Equivalent on October 7, 1985, 28 days after the submission was received.
What is the product code of K853761?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.