6.5 MM CANCELLOUS BONE SCREW— 510(k) K931665
Substantially EquivalentEncore Orthopedics, Inc.
FDA 510(k) clearance K931665 for 6.5 MM CANCELLOUS BONE SCREW, Substantially Equivalent on 1994-02-17. Applicant: Encore Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Encore Orthopedics, 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
- Traditional
- Location
- Austin, TX, US
Recent devices under product code HWC
view allMore clearances from Encore Orthopedics, 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 K931665
K-number listed on FDA's recall record- Z-0139-2013 — 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
- Z-2146-2012 — djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K931665.
Data sourced from openFDA. This site is unofficial and independent of the FDA.