Identity
- Trade Name
- Integra® Spider™ Limted Wrist Fusion System FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- The Spider™ and Mini Spider™ Limited Wrist Fusion System consist of two stainless steel plates, featuring an 8-hole and a 6-hole design. Both plates have a unique three-dimensional design optimized for four-corner and other limited wrist fusion procedures. FDA UDI
- Model / Reference
- SPIDERSET FDA UDI
- Description
- The Spider™ and Mini Spider™ Limited Wrist Fusion System consist of two stainless steel plates, featuring an 8-hole and a 6-hole design. Both plates have a unique three-dimensional design optimized for four-corner and other limited wrist fusion procedures. FDA UDI
Identifiers
- Catalog Number
- SPIDERSET FDA UDI
- Primary DI / UDI-DI
- 10381780064329 FDA UDI
- 510(k) Number
- K991873 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Integra® Spider™ Limted Wrist Fusion System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K991873 also covers:
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted Wrist Fusion System — Ascension Orthopedics, Inc.
- Integra® Spider™ Limted 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI c77898c2-15a7-4877-910e-d92b91948331 38 fields · synced May 30, 2026