MODIFICATION TO HBS HEADLESS BONE SCREW— 510(k) K101030
Substantially EquivalentBiopro, Inc.
FDA 510(k) clearance K101030 for MODIFICATION TO HBS HEADLESS BONE SCREW, Substantially Equivalent on 2010-06-03. Applicant: Biopro, Inc.. Device class: 2.
Clearance details
- Applicant
- Biopro, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Port Huron, MI, US
Recent devices under product code HWC
view allMore clearances from Biopro, Inc.
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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 K101030
K-number listed on FDA's recall record- Z-2239-2019 — K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.
- Z-2259-2019 — K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101030.
Data sourced from openFDA. This site is unofficial and independent of the FDA.