BLACK WIDOW ANTERIOR BUTTRESS PLATE— 510(k) K081770
Substantially EquivalentOmni Surgical, L.P.
FDA 510(k) clearance K081770 for BLACK WIDOW ANTERIOR BUTTRESS PLATE, Substantially Equivalent on 2009-04-02. Applicant: Omni Surgical, L.P.. Device class: 2.
Clearance details
- Applicant
- Omni Surgical, L.P.
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code KWQ
view allMore clearances from Omni Surgical, L.P.
view allAdverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K081770
K-number listed on FDA's recall record- Z-0886-2017 — Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
- Z-0887-2017 — Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081770.
Data sourced from openFDA. This site is unofficial and independent of the FDA.