Identity
- Trade Name
- SPARK - Instruments FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, reusable FDA UDI
- Device Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - General Instrument FDA UDI
- Model / Reference
- 445-126/65 FDA UDI
- Description
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - General Instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04026575216703 FDA UDI
- FDA Product Code
- HXQ FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic intraoperative positioning pin, reusable
SPARK - Instruments by WALDEMAR LINK GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI f2b467d2-3393-4c2b-878b-7c6df2bb9802 33 fields · synced Jun 6, 2026