Identity
- Trade Name
- PyroCarbon Lunate FDA UDI
- Generic Name
- Carpal lunate prosthesis FDA UDI
- Device Name
- LUNATE SZ. 02 FDA UDI
- Model / Reference
- LUN-710-02-WW FDA UDI
- Description
- LUNATE SZ. 02 FDA UDI
Identifiers
- Catalog Number
- LUN-710-02-WW FDA UDI
- Primary DI / UDI-DI
- 00885556858738 FDA UDI
- 510(k) Number
- K080997 FDA UDI
- FDA Product Code
- KWN FDA UDI
- GMDN Term
- Carpal lunate prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3750 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
No
FDA UDI
Category: Carpal lunate prosthesis
PyroCarbon Lunate by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carpal lunate prosthesis.
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED · Class II
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED · Class II
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED · Class II
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc. · Class II
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED · Class II
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED · Class II
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED · Class II
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED · Class II
Cleared under the same submission
K080997 also covers:
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc.
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc.
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc.
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc.
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- PyroCarbon Lunate — Smith & Nephew, Inc.
- PyroCarbon Lunate — Smith & Nephew, Inc.
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 |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI b12b3a24-4660-4e73-87ea-476ec35062dd 36 fields · synced Jun 8, 2026