TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS— 510(k) K141263
Substantially EquivalentBiomet Manufacturing Corp
FDA 510(k) clearance K141263 for TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS, Substantially Equivalent on 2014-11-19. Applicant: Biomet Manufacturing Corp. Device class: 2.
Clearance details
- Applicant
- Biomet Manufacturing Corp
- Product code
- Code JDR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code JDR
view allMore clearances from Biomet Manufacturing Corp
view allAdverse events under product code JDR
product code JDR- Injury
- 726
- Malfunction
- 663
- Other
- 1
- Total
- 1,390
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 K141263
K-number listed on FDA's recall record- Z-0809-2022 — BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
- Z-1363-2015 — ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141263.
Data sourced from openFDA. This site is unofficial and independent of the FDA.