Identity
- Trade Name
- KLIMT FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Paddle Distractor, 7mm FDA UDI
- Model / Reference
- 367.7007 FDA UDI
- Description
- Paddle Distractor, 7mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841732165380 FDA UDI
- 510(k) Number
- K233947 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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: General internal orthopaedic fixation system implantation kit
Klimt by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
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- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
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- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Cleared under the same submission
K233947 also covers:
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
- KLIMT — CTL Medical Corporation
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
- CTL Medical Corporation
Sources (1)
- FDA UDI 1c924a0f-e999-419c-94c3-e9404e6c6d3b 35 fields · synced May 30, 2026