Identity
- Trade Name
- KLIMT FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Disc Scraper, 6mm FDA UDI
- Model / Reference
- 367.7106 FDA UDI
- Description
- Disc Scraper, 6mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841732165472 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
MR Conditional 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.
- Matrixx System — NEXXT SPINE LLC · Class I
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- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- 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 b853b040-283b-454d-becf-339a88290c09 35 fields · synced Jun 8, 2026