SPINAL SURGERY FRAME— 510(k) K875291

Clearance details

Applicant

T. Korossurgical Instruments Corp.

Product code

Code BWN

Device class

Class 1

Regulation

21 CFR 878.4950

Advisory panel

General, Plastic Surgery

Date received

1987-12-30

Decision date

1988-01-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Moorepark, CA, US

• K942699 — AIRFRAME SURGICAL DRAPE SUPPORT1994-07-13
• K935441 — INFINITECH BREATH EZ1994-02-07
• K925005 — ISI SELF-SUPPORTING ARM1993-04-29
• K922288 — HOLDER, PEDIATRIC POSITION1993-02-10
• K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M1991-04-02

• K001915 — GRAFT MARKER RING2001-04-27
• K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE2000-12-04
• K954016 — VIDEOSCOPE W/IRRIGATION SHEATH1996-01-25
• K953998 — DISCETOME TISSUE ASPIRATOR1995-12-04
• K954014 — PERCUTANEOUS DISCECTOMY CANNULA SYSTEM1995-11-06

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →