Bone Cutting Instruments & Accessories
FDA 510(k) K874961 · Solway, Inc.
510(k) numberK874961
Submission
- Device name
- Bone Cutting Instruments & Accessories
- Applicant
- Solway, Inc.
Hollywood, FL, US - Received
- December 2, 1987
- Decision date
- December 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDR – Saw, Manual And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851787 | 27-100 to 29-130 Various Bone Saws-Charriere, SattGDR · Traditional | Artiberia | 06/20/1985SE |
More from Artiberia
| 510(k) | Device | Decision |
|---|---|---|
| K874960 | Cardiovascular Surgical InstrumentsDWS · Traditional | 02/05/1988SE |
| K874962 | Forceps Cliprack Ventricular Cannula Saws SpatulasHAO · Traditional | 02/02/1988SE |
| K874956 | Self-Retaining Retractor for NeurosurgeryGZT · Traditional | 01/28/1988SE |
| K874964 | Dental Hand InstrumentsEKJ · Traditional | 01/27/1988SE |
| K875043 | Rongeur (Neurosurgical Instruments)HAE · Traditional | 01/22/1988SE |
| K874966 | Tuning ForksGWX · Traditional | 01/04/1988SE |
| K874965 | Manual Surgical Instruments for General UseHTD · Traditional | 12/30/1987SE |
| K874959 | Vascular ClampHXD · Traditional | 12/30/1987SE |
| K874954 | Manual RongeurHTX · Traditional | 12/30/1987SE |
| K874952 | Manual Cranial Drill, Burr, Trephine & AccessoriesHBG · Traditional | 12/30/1987SE |
Questions and answers
When was Bone Cutting Instruments & Accessories cleared by the FDA?
Bone Cutting Instruments & Accessories (K874961) received a 510(k) decision of Substantially Equivalent on December 30, 1987, 28 days after the submission was received.
What is the product code of K874961?
The FDA product code is GDR – Saw, Manual And Accessories, a Class I (low risk) device regulated under 21 CFR 878.4800.