Chop Spine Frame
FDA 510(k) K883295 · Avec Scientific Design Corp.
510(k) numberK883295
Submission
- Device name
- Chop Spine Frame
- Applicant
- Avec Scientific Design Corp.
Philadelphia, PA, US - Received
- August 4, 1988
- Decision date
- August 23, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LWG – Surgical Table Cushion
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LWG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882520 | Shoulder Bolster, Knee, Ankle & Leg Support PadsLWG · Traditional | Karlin Technology, Inc. | 07/18/1988SE |
| K874494 | Kambin Laminectomy FrameLWG · Traditional | Avec Scientific Design Corp. | 11/23/1987SE |
| K873690 | Cedar(Tm) Pelvic CushionLWG · Traditional | Cedar Surgical, Inc. | 10/26/1987SE |
More from Cedar Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874494 | Kambin Laminectomy FrameLWG · Traditional | 11/23/1987SE |
| K872544 | Irrigation Pressure MonitorHRX · Traditional | 09/04/1987SE |
| K871981 | Bilateral Continuous Passive Motion DeviceBXB · Traditional | 06/17/1987SE |
| K871900 | Over Drape Leg HolderKQZ · Traditional | 06/16/1987SE |
| K871982 | Tourniquet Pressure RegulatorKCY · Traditional | 06/09/1987SE |
Questions and answers
When was Chop Spine Frame cleared by the FDA?
Chop Spine Frame (K883295) received a 510(k) decision of Substantially Equivalent on August 23, 1988, 19 days after the submission was received.
What is the product code of K883295?
The FDA product code is LWG – Surgical Table Cushion, a Class I (low risk) device regulated under 21 CFR 878.4950.