Drivers
FDA 510(k) K781450 · Orthopedic Equipment Co., Inc.
510(k) numberK781450
Submission
- Device name
- Drivers
- Applicant
- Orthopedic Equipment Co., Inc.
Mchenry, IL, US - Received
- August 23, 1978
- Decision date
- September 27, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GFC – Driver, Surgical, Pin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K780255 | Needle DriverGFC · Traditional | Scanlan Intl., Inc. | 04/18/1978SE |
More from Scanlan Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834035 | Universal Self-Aligning Acetabular ComJDI · Traditional | 06/19/1984SE |
| K841189 | Oec/Rezaian Spinal FixatorKWQ · Traditional | 05/16/1984SE |
| K800530 | Schlein Tri-Surface AnkleHSN · Traditional | 04/02/1980SE |
| K781445 | SpreaderGAD · Traditional | 09/27/1979SE |
| K790247 | Tourniquet Test Gage · Traditional | 02/26/1979SE |
| K790209 | Filter System, Altner DisposableGAZ · Traditional | 02/26/1979SE |
| K781451 | Flat WrenchHXS · Traditional | 09/27/1978SE |
| K781449 | Harrington Spinal ElevatorGEG · Traditional | 09/27/1978SE |
| K781448 | Harrington Hook ClampGEN · Traditional | 09/27/1978SE |
| K781447 | Threaded Rod ClampGEN · Traditional | 09/27/1978SE |
Questions and answers
When was Drivers cleared by the FDA?
Drivers (K781450) received a 510(k) decision of Substantially Equivalent on September 27, 1978, 35 days after the submission was received.
What is the product code of K781450?
The FDA product code is GFC – Driver, Surgical, Pin, a Class I (low risk) device regulated under 21 CFR 878.4820.