Identity
- Trade Name
- LUMIS™ FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- SETSCREW SUPPORT FDA UDI
- Model / Reference
- MS1-A251 FDA UDI
- Description
- SETSCREW SUPPORT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663136006659 FDA UDI
- 510(k) Number
- K112607 FDA UDI
- FDA Product Code
- MNI FDA UDIKWP FDA UDINKB FDA UDIKWQ FDA UDIMNH FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI888.3060 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
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 procedure kit, non-medicated, reusable
A comprehensive medical device directory, featuring LUMIS, a non-medicated orthopaedic surgical procedure kit for spinal fixation.
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Cleared under the same submission
K112607 also covers:
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
- LUMIS™ — Spine Vision, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spine Vision, Inc.
Sources (1)
- FDA UDI 44fb79c0-008c-4b2d-8660-b6331673eb4b 35 fields · synced Jul 13, 2026