Identity
- Trade Name
- Modular Fixation System FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- Modular Tip - Lamina Spreader - Left FDA UDI
- Model / Reference
- 148-607L FDA UDI
- Description
- Modular Tip - Lamina Spreader - Left FDA UDI
Identifiers
- Catalog Number
- 148-607L FDA UDI
- Primary DI / UDI-DI
- 00190837076405 FDA UDI
- 510(k) Number
- K183430 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone lever/elevator, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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 lever/elevator, reusable
Modular Fixation System by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone lever/elevator, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class I
- Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
- HAT-TRICK — Smith & Nephew, Inc. · Class I
- ORTHOMED — ORTHO-MED, INC. · Class I
- Symmetry Allerdyce — SYMMETRY SURGICAL INC. · Class I
- Life Instruments — Life Instrument Corporation · Class I
Cleared under the same submission
K183430 also covers:
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation System — Life Spine, Inc.
- Modular Fixation 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Life Spine, Inc.
Sources (1)
- FDA UDI cafe012c-d89e-49aa-8596-eb975df44374 35 fields · synced May 30, 2026