Raylor(Tm) Periosteal Elevators
FDA 510(k) K864421 · Cedar Surgical, Inc.
510(k) numberK864421
Submission
- Device name
- Raylor(Tm) Periosteal Elevators
- Applicant
- Cedar Surgical, Inc.
Minnetonka, MN, US - Received
- November 10, 1986
- Decision date
- November 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEG – Elevator, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891899 | Elevators, Various TypesGEG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K891894 | Elevators-Cottle,Mckenty,Goldman,Joseph,ConverseGEG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K890365 | Septum ElevatorGEG · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890253 | Surgical ElevatorGEG · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890230 | Ligature NeedlesGEG · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K872491 | 1.1 Twist Drills and 1.2 Cortical DrillsGEG · Traditional | Micro-Aire Surgical Instruments, Inc. | 07/16/1987SE |
| K870781 | Acromed Wallie-Heinig Disector/ElevatorsGEG · Traditional | Buckman Co., Inc. | 03/09/1987SE |
| K870591 | Elevator, Cobb SpinalGEG · Traditional | Military Engineering, Inc. | 02/26/1987SE |
| K870126 | Femur WrenchGEG · Traditional | Orthopedic Systems, Inc. | 02/03/1987SE |
| K834176 | H.R. Jakobi Surg. Instruments 40/41GEG · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
More from Imm Enterprises , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K873692 | Raylor(Tm) Drill StopHBE · Traditional | 12/17/1987SE |
| K872281 | Raylor Fusion FunnelHXR · Traditional | 11/02/1987SE |
| 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 |
| 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(Tm) Periosteal Elevators cleared by the FDA?
Raylor(Tm) Periosteal Elevators (K864421) received a 510(k) decision of Substantially Equivalent on November 26, 1986, 16 days after the submission was received.
What is the product code of K864421?
The FDA product code is GEG – Elevator, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.