Product code LZY— Orthopedic
BHR BIPOLAR FEMORAL HEAD COMPONENT
- Classification name
- Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code LZY
FDA has cleared devices under product code LZY between 1989 and 2023, 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
- 2023
- 2011
- 1998
- 1993
- 1992
- 1990
- 1989
Top applicants under product code LZY
Adverse events under product code LZY
product code LZY- Injury
- 431
- Total
- 431
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 LZY
- K231448 — TANDEM Hip System
- K111145 — ENDO HEAD
- K974442 — PRE-POWDERED NITRILE EXAMINATION GLOVES
- K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT
- K915548 — IONGUARD TITANIUM MODULAR HEADS
- K903084 — MODULAR CATHCART FRACTURE SYSTEM
- K896580 — UNI-POLAR HEAD
- K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
Data sourced from openFDA. This site is unofficial and independent of the FDA.