Product code NDG— Orthopedic
SYNTHES (USA) SPHERICAL WASHERS
- Classification name
- Washer, Bolt, Nut, Non-Spinal, Metallic
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code NDG
FDA has cleared device under product code NDG, all in 2005, filed by 1 applicant company. 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.
Top applicants under product code NDG
Recent clearances under product code NDG
Data sourced from openFDA. This site is unofficial and independent of the FDA.