← FDA Medical Device Classifications
Plate, Cranioplasty, Preformed, Non-Alterable
GXN · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5330
Classification
- FDA Product Code
GXN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 882.5330
- Review panel
- NE
- Medical specialty
- Neurology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 55
- Registered establishments
- 44
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown