← FDA Medical Device Classifications
Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis
PIX · Not classified · Unknown
Classification
- FDA Product Code
PIX- Device class
- Not classified
- Regulation
- —
- Review panel
- OR
- Medical specialty
- Unknown
- Submission type
- 3
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown