Surgical Table Cushion
FDA product code LWG · Class I (low risk) · 21 CFR 878.4950 · General, Plastic Surgery
4510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883295 | Chop Spine FrameLWG · Traditional | Avec Scientific Design Corp. | 08/23/1988SE |
| 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 |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1925-2016 Class II | Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the…The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying… | Berchtold Corp. | 04/19/2016Terminated |