← FDA Medical Device Classifications
Instrument, Surgical, Sonic And Accessory/Attachment
JDX · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.4580
Classification
- FDA Product Code
JDX- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 888.4580
- Review panel
- OR
- Medical specialty
- Orthopedic
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 23
- Registered establishments
- 36
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown