Brainlab Compatible K2M Navigation Instruments
FDA UDIClass I (US FDA UDI)
by K2m, Inc.
Identity
- Trade Name
- Brainlab Compatible K2M Navigation Instruments FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, single-use FDA UDI
- Device Name
- Adjustable Drill Bit Size 2.8 mmYUKON FDA UDI
- Model / Reference
- 7601-N90010-B FDA UDI
- Description
- Adjustable Drill Bit Size 2.8 mmYUKON FDA UDI
Identifiers
- Catalog Number
- 7601-N90010-B FDA UDI
- Primary DI / UDI-DI
- 10888857415911 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Internal spinal fixation procedure kit, single-use 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 2.8 Millimeter FDA UDI
Category: Internal spinal fixation procedure kit, single-use
Brainlab Compatible K2M Navigation Instruments are designed for precise internal spinal fixation and spinal fusion cage implantation procedures, utilizing adjustable drill bit sizes to ensure accurate placement. These single-use instruments feature a durable design, sterilization methods, and are exempt from direct marking requirements.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- K2m, Inc.
Sources (1)
- FDA UDI fc360373-ee2a-4bee-8cda-c96bd3e7b672 36 fields · synced Jul 21, 2026