Identity
- Trade Name
- Alignment Instrument, Single End, Right FDA UDI
- Generic Name
- Orthopaedic fixation implant alignment tool FDA UDI
- Model / Reference
- 201.040.02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851599007457 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation implant alignment tool 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
No
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
A comprehensive medical device directory entry for the Alignment Instrument, Single End, Right. The device is a surgical instrument designed to facilitate the correct orientation (alignment) of orthopaedic fixation implants during surgery. It allows surgeons to engage this device with implants and align them in the desired configuration.
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
- Jace Medical, Llc
Sources (1)
- FDA UDI 2ffd35c9-01b4-42f8-bc2b-62ed57616d01 33 fields · synced Jun 20, 2026