Product code LRN— Orthopedic
J-FX CERCLAGE SYSTEM
- Classification name
- Wire, Surgical
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code LRN
FDA has cleared devices under product code LRN between 1987 and 2000, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2000
- 1999
- 1997
- 1995
- 1994
- 1990
- 1989
- 1987
Top applicants under product code LRN
Adverse events under product code LRN
product code LRN- Injury
- 185
- Total
- 185
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 →
Recent clearances under product code LRN
- K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
- K990355 — STAINLESS STEEL SOFT SUTURE WIRE
- K971682 — J-FX CERCLAGE SYSTEM
- K952783 — OXBORO-MEDICAL PIN COVERS
- K942603 — ORTHOPAEDIC WIRES
- K900926 — TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)
- K892651 — SONGER WIRING SYSTEM
- K864375 — TYPE 316L COTTER WIRE
Data sourced from openFDA. This site is unofficial and independent of the FDA.