Solanas

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name: Solanas FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: CoCr Posterior Cervical Rod, 3.3mm X 75mm FDA UDI
Model / Reference: 63011-075 FDA UDI
Description: CoCr Posterior Cervical Rod, 3.3mm X 75mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00190376062594 FDA UDI
510(k) Number: K191185 FDA UDI
FDA Product Code: KWP FDA UDI
NKB FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.3 Millimeter FDA UDI
Length — 75 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system rod

The Solanas device, a CoCr Posterior Cervical Rod, 3.3mm X 75mm, is an orthopedic implant used to stabilize and immobilize spinal segments in the treatment of various spinal instabilities or deformities. This implant is designed as a longitudinal connecting element for internal spinal fixation, providing immobilization and stabilization.

Similar devices

Also classified as Bone-screw internal spinal fixation system rod.

The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II

Cleared under the same submission

K191185 also covers:

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: Alphatec Spine, Inc.

Sources (1)

FDA UDI d03da843-b00b-48f3-8bec-49dd26c32c33 36 fields · synced Jul 20, 2026