StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis— 510(k) K160071
Substantially EquivalentBiomet, Inc.
FDA 510(k) clearance K160071 for StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis, Substantially Equivalent on 2016-06-16. Applicant: Biomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet, Inc.
- Product code
- Code MBB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code MBB
view allMore clearances from Biomet, Inc.
view allAdverse events under product code MBB
product code MBB- Death
- 27
- Injury
- 1,412
- Malfunction
- 551
- Total
- 1,990
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 K160071
K-number listed on FDA's recall record- Z-1657-2020 — BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
- Z-1658-2020 — BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
- Z-1659-2020 — BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
- Z-1660-2020 — BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
- Z-1661-2020 — BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160071.
Data sourced from openFDA. This site is unofficial and independent of the FDA.