Identity
- Trade Name
- MD Vue Lateral Access FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Light Cable Case (Empty) FDA UDI
- Model / Reference
- 54-SC-3000 FDA UDI
- Description
- Light Cable Case (Empty) FDA UDI
Identifiers
- Catalog Number
- 54-SC-3000 FDA UDI
- Primary DI / UDI-DI
- 00840019919708 FDA UDI
- 510(k) Number
- K092193 FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
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
MD Vue Lateral Access by Precision Spine, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
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- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT — FX SOLUTIONS · Class I
Cleared under the same submission
K092193 also covers:
- AccuFit RP System — Precision Spine, Inc.
- AccuFit RP System — Precision Spine, Inc.
- Intervertebral Body Fusion Device — Precision Spine, Inc.
- Intervertebral Body Fusion Device — Precision Spine, Inc.
- MD Vue Discectomy — Precision Spine, Inc.
- MD Vue Discectomy — Precision Spine, Inc.
- MD-Vue Lateral Access System — Precision Spine, Inc.
- MD-Vue™ Lateral Discectomy System — Precision Spine, Inc.
- MD-Vue™ Lateral Discectomy System — Precision Spine, Inc.
- MD-Vue™ Lateral Discectomy System — Precision Spine, Inc.
- ShurFit Interbody Device — Precision Spine, Inc.
- ShurFit Interbody Device — Precision Spine, 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Precision Spine, Inc.
Sources (1)
- FDA UDI f8763d7d-03f4-41c6-8f2e-ec1636330ca9 35 fields · synced Jun 7, 2026