Identity
- Trade Name
- Movement® FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant. FDA UDI
- Model / Reference
- TRL89010PPT FDA UDI
- Description
- The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780236863 FDA UDI
- 510(k) Number
- K102549 FDA UDI
- FDA Product Code
- LZJ FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant template, reusable
Movement® by Ascension Orthopedics, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
Cleared under the same submission
K102549 also covers:
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement Great Toe System — Smith & Nephew, Inc.
- Movement Great Toe System — Smith & Nephew, Inc.
- Movement Great Toe System — Smith & Nephew, Inc.
- Movement Great Toe System — Smith & Nephew, Inc.
- Movement Great Toe System — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI d67d76b0-7c06-47a8-a304-a3460c95c2d7 37 fields · synced May 30, 2026