Raylor(Tm) Depth Gauge
FDA 510(k) K864426 · Cedar Surgical, Inc.
510(k) numberK864426
Submission
- Device name
- Raylor(Tm) Depth Gauge
- 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
- HTJ – Gauge, Depth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4300
- Specialty
- Orthopedic
Other 510(k)s with product code HTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940480 | Acufex Sub-Acromial Space Measuring DeviceHTJ · Traditional | Acufex Microsurgical, Inc. | 03/23/1994SE |
| K925335 | Acufex Intra Articular Measuring DeviceHTJ · Traditional | Acufex Microsurgical, Inc. | 12/29/1992SE |
| K873191 | Acromed Interbody Depth GaugesHTJ · Traditional | Buckman Co., Inc. | 09/09/1987SE |
More from Buckman Co., Inc.
| 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 |
| 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(Tm) Depth Gauge cleared by the FDA?
Raylor(Tm) Depth Gauge (K864426) 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 K864426?
The FDA product code is HTJ – Gauge, Depth, a Class I (low risk) device regulated under 21 CFR 888.4300.