Identity
- Trade Name
- Solstice Occipito-Cervico-Thoracic System FDA UDI
- Generic Name
- Orthopaedic implantable-device cutter FDA UDI
- Device Name
- 3.5mm Rod Cutter FDA UDI
- Model / Reference
- 117-778 FDA UDI
- Description
- 3.5mm Rod Cutter FDA UDI
Identifiers
- Catalog Number
- 117-778 FDA UDI
- Primary DI / UDI-DI
- 00190837039103 FDA UDI
- 510(k) Number
- K090343 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Orthopaedic implantable-device cutter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 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 implantable-device cutter
Solstice Occipito-Cervico-Thoracic System by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implantable-device cutter.
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- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- PLUG CUTTER — SONTEC INSTRUMENTS, INC. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
Cleared under the same submission
K090343 also covers:
- Solstice — Life Spine, Inc.
- Solstice — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc.
- Solstice Occipito-Cervico-Thoracic 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 |
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Manufacturer
- Manufacturer
- Life Spine, Inc.
Sources (1)
- FDA UDI c47aa339-44f4-4959-98ed-3364a617e9b8 35 fields · synced May 30, 2026