Raylor Fusion Funnel
FDA 510(k) K872281 · Cedar Surgical, Inc.
510(k) numberK872281
Submission
- Device name
- Raylor Fusion Funnel
- Applicant
- Cedar Surgical, Inc.
Minnetonka, MN, US - Received
- June 16, 1987
- Decision date
- November 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXR – Spatula, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HXR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983882 | Micro Endoscope-Stainless Steel, Model MMD-1300, Micro Endoscope-Polyimide,Model MMD-1400HXR · Traditional | Micro-Medical Devices, Inc. | 03/15/1999SE |
| K873387 | Video Arthroscope, 1.7MM X 55 MMHXR · Traditional | Arthropedics, Inc. | 11/25/1987SE |
| K853436 | H-H Hunter Passive Tendon ImplantHXR · Traditional | Holter-Hausner Intl. | 10/16/1985SE |
More from Holter-Hausner Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K873692 | Raylor(Tm) Drill StopHBE · Traditional | 12/17/1987SE |
| K873690 | Cedar(Tm) Pelvic CushionLWG · Traditional | 10/26/1987SE |
| K873691 | Cedar(Tm) Retractor RingGZT · Traditional | 09/28/1987SE |
| K864425 | Raylor(Tm) Dissecting HookGDG · Traditional | 12/12/1986SE |
| K864426 | Raylor(Tm) Depth GaugeHTJ · Traditional | 11/26/1986SE |
| K864424 | Raylor(Tm) Protective RetractorGAD · Traditional | 11/26/1986SE |
| K864421 | Raylor(Tm) Periosteal ElevatorsGEG · Traditional | 11/26/1986SE |
| K864423 | Raylor(Tm) Osteotomes · Traditional | 11/24/1986SE |
| K864422 | Raylor(Tm) MalletHWA · Traditional | 11/24/1986SE |
| K863416 | Raylor Mini-ProbeHAO · Traditional | 09/24/1986SE |
Questions and answers
When was Raylor Fusion Funnel cleared by the FDA?
Raylor Fusion Funnel (K872281) received a 510(k) decision of Substantially Equivalent on November 2, 1987, 139 days after the submission was received.
What is the product code of K872281?
The FDA product code is HXR – Spatula, Orthopedic, a Class I (low risk) device regulated under 21 CFR 878.4800.