X-Fix Line Additions— 510(k) K151881
Substantially EquivalentVilex IN Tennessee, Inc.
FDA 510(k) clearance K151881 for X-Fix Line Additions, Substantially Equivalent on 2016-03-24. Applicant: Vilex IN Tennessee, Inc.. Device class: 2.
Clearance details
- Applicant
- Vilex IN Tennessee, Inc.
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcminnville, TN, US
Recent devices under product code KTT
view allMore clearances from Vilex IN Tennessee, Inc.
view allAdverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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 K151881
K-number listed on FDA's recall record- Z-0277-2023 — Orthex Large Bone Shoulder Bolt, model no. AS-17
- Z-1678-2022 — Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151881.
Data sourced from openFDA. This site is unofficial and independent of the FDA.