Identity
- Trade Name
- CosmoLock Pedicle Screw System FDA UDI
- Generic Name
- Orthopaedic surgical distractor, internal FDA UDI
- Device Name
- Modular Tip, Bifid, Left FDA UDI
- Model / Reference
- 11-K03-6010 FDA UDI
- Description
- Modular Tip, Bifid, Left FDA UDI
Identifiers
- Primary DI / UDI-DI
- B07311K0360100 FDA UDI
- FDA Product Code
- HWN FDA UDI
- GMDN Term
- Orthopaedic surgical distractor, internal 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
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
Category: Orthopaedic surgical distractor, internal
CosmoLock Pedicle Screw System by Kalitec Direct LLC — 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
- Kalitec Direct LLC
Sources (1)
- FDA UDI b9e3a22b-5446-4d60-ae24-db6b9e4c09df 33 fields · synced Jun 7, 2026