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Alpine Hip Stem +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K141001
Identifiers
- 510(k) Number
- K141001 FDA 510(k)
- FDA Product Code
- LPH FDA 510(k)
- Models / Variants
- Alpine Hip Stem FDA 510(k)Alpine Ha Hip Stem FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3358 FDA 510(k)
- Regulation Number
- 888.3358 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Our ALPINE HIP STEM and ALPINE HA HIP STEM devices are designed to provide reliable and durable hip replacement solutions for orthopedic professionals. These semi-constrained, porous uncemented prostheses offer a unique combination of stability, strength, and comfort, making them an ideal choice for patients with complex hip conditions.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141001 | Class II | Active |
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Manufacturer
- Manufacturer
- Ortho Development
Sources (1)
- FDA 510(k) K141001 24 fields · synced Jul 11, 2026