Identity
- Trade Name
- Integra® Total Wrist Fusion System FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- Total Wrist Fusion cortical screw FDA UDI
- Model / Reference
- 303220CS FDA UDI
- Description
- Total Wrist Fusion cortical screw FDA UDI
Identifiers
- Catalog Number
- 303220CS FDA UDI
- Primary DI / UDI-DI
- 10381780066347 FDA UDI
- 510(k) Number
- K093163 FDA UDI
- FDA Product Code
- HRS FDA UDILXT FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Integra® Total Wrist Fusion System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.
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- ACUMED — ACUMED LLC · Class II
- NCB® — Zimmer, Inc. · Class II
- ACUMED — ACUMED LLC · Class II
- NCB® — Zimmer, Inc. · Class II
- NCB® — Zimmer, Inc. · Class II
Cleared under the same submission
K093163 also covers:
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Total Wrist Fusion System — Ascension Orthopedics, 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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 5b910c7a-22fa-431e-9d27-0770db22b48d 38 fields · synced Jun 8, 2026