Orthopedic Forceps
FDA 510(k) K780397 · Orthopedic Equipment Co., Inc.
510(k) numberK780397
Submission
- Device name
- Orthopedic Forceps
- Applicant
- Orthopedic Equipment Co., Inc.
Mchenry, IL, US - Received
- March 13, 1978
- Decision date
- March 22, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTX – Rongeur
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874954 | Manual RongeurHTX · Traditional | Solway, Inc. | 12/30/1987SE |
| K841621 | Back Radius CutterHTX · Traditional | Plastafil, Inc. | 09/20/1984SE |
| K841620 | Front Radius CutterHTX · Traditional | Plastafil, Inc. | 09/20/1984SE |
| K760325 | Surgical Instruments, OrthopedicHTX · Traditional | Depuy, Inc. | 08/03/1976SE |
More from Depuy, 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 |
| K781450 | DriversGFC · Traditional | 09/27/1978SE |
| K781449 | Harrington Spinal ElevatorGEG · Traditional | 09/27/1978SE |
| K781448 | Harrington Hook ClampGEN · Traditional | 09/27/1978SE |
Questions and answers
When was Orthopedic Forceps cleared by the FDA?
Orthopedic Forceps (K780397) received a 510(k) decision of Substantially Equivalent on March 22, 1978, 9 days after the submission was received.
What is the product code of K780397?
The FDA product code is HTX – Rongeur, a Class I (low risk) device regulated under 21 CFR 888.4540.