HAMMERLOC TM TIBIAL FIXATION DEVICE— 510(k) K103145
Substantially EquivalentBiomet Sports Medicine
FDA 510(k) clearance K103145 for HAMMERLOC TM TIBIAL FIXATION DEVICE, Substantially Equivalent on 2011-02-09. Applicant: Biomet Sports Medicine. Device class: 2.
Clearance details
- Applicant
- Biomet Sports Medicine
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code MBI
view allMore clearances from Biomet Sports Medicine
view all- K140908 — JUGGERKNOT MINI SOFT ANCHOR
- K122437 — NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
- K123485 — JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
- K110879 — BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
- K111564 — MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
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 K103145
K-number listed on FDA's recall record- Z-1071-2018 — TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
- Z-1072-2018 — TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103145.
Data sourced from openFDA. This site is unofficial and independent of the FDA.