Identity
- Trade Name
- Crescendo Patella Component 32x8mm FDA UDI
- Generic Name
- Polyethylene patella prosthesis FDA UDI
- Model / Reference
- 1-01-07-7003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701089524148 FDA UDI
- 510(k) Number
- K170613 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Polyethylene patella prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polyethylene patella prosthesis
Crescendo Patella Component 32x8mm by Amplitude — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene patella prosthesis.
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Cleared under the same submission
K170613 also covers:
- Crescendo Femoral Component Cemented - CR Size 2L — Amplitude
- Crescendo Femoral Component Cemented - PS Size 2L — Amplitude
- Crescendo Femoral Component Cemented - PS Size 5R — Amplitude
- Crescendo Meniscal Insert CR Standard 11mm Size 0 — Amplitude
- Crescendo Meniscal Insert CR Standard 12mm Size 2 — Amplitude
- Crescendo Meniscal Insert CR Standard 12mm Size 5 — Amplitude
- Crescendo Meniscal Insert CR Standard 13mm Size 3 — Amplitude
- Crescendo Meniscal Insert CR Standard 15mm Size 5 — Amplitude
- Crescendo Meniscal Insert CR Standard 17mm Size 3 — Amplitude
- Crescendo Meniscal Insert CR Ultracongruent 12mm Size 2 — Amplitude
- Crescendo Meniscal Insert CR Ultracongruent 12mm Size 5 — Amplitude
- Crescendo Meniscal Insert CR Ultracongruent 15mm Size 3 — Amplitude
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amplitude
Sources (1)
- FDA UDI 2803c5b5-d376-46df-b417-b22155cb183d 34 fields · synced Jun 8, 2026