Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
- Device Name
- The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arthroplasty is intended for resurfacing of the 1st metatarsal head or the base of the proximal phalanx. The total arthroplasty is intended for resurfacing of the base of the 1st metatarso-phalangeal joint. This set includes metatarsal, proximal phalanx hemi, and proximal phalanx total trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials. FDA UDI
- Model / Reference
- MRADHDINSTP FDA UDI
- Description
- The Movement Great Toe System is used for hemi- and total-arthroplasty procedures. The hemi arthroplasty is intended for resurfacing of the 1st metatarsal head or the base of the proximal phalanx. The total arthroplasty is intended for resurfacing of the base of the 1st metatarso-phalangeal joint. This set includes metatarsal, proximal phalanx hemi, and proximal phalanx total trials to evaluate the size and fit of the appropriate implant. Instruments are also included to assist with the trials. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780235002 FDA UDI
- 510(k) Number
- K032686 FDA UDI
- FDA Product Code
- KWI FDA UDI
- GMDN Term
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3170 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® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K032686 also covers:
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Ascension® Modular Radial Head — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — 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 daa913e9-30f1-4c64-9769-a604f07065a8 37 fields · synced Jun 8, 2026