← FDA Medical Device Classifications

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

LPH · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3358

Classification

FDA Product Code

LPH

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 888.3358

Review panel

OR

Medical specialty

Orthopedic

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

559

Registered establishments

264

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown