Identity
- Trade Name
- FS3 Facet Screw Spinal System FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- Access Needle, 11 GA FDA UDI
- Model / Reference
- 144-020 FDA UDI
- Description
- Access Needle, 11 GA FDA UDI
Identifiers
- Catalog Number
- 144-020 FDA UDI
- Primary DI / UDI-DI
- 00190837041236 FDA UDI
- 510(k) Number
- K090865 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Bone access cannula FDA UDI
Classification
- Device Class
- U 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: Bone access cannula
FS3 Facet Screw Spinal System by Life Spine, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone access cannula.
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- Arthrex® — Arthrex, Inc. · Class I
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- Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II
- Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II
Cleared under the same submission
K090865 also covers:
- FS3 — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life Spine, Inc.
- FS3 Facet Screw Spinal System — Life 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 | Class U | Pending data |
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Manufacturer
- Manufacturer
- Life Spine, Inc.
Sources (1)
- FDA UDI e7774a3b-cac5-4321-aa31-811762719fa4 35 fields · synced Jun 6, 2026