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Revolve

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name
REVOLVE FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
8.5mm REVOLVE Polyaxial Pedicle Screw, 70mm FDA UDI
Model / Reference
185.081 FDA UDI
Description
8.5mm REVOLVE Polyaxial Pedicle Screw, 70mm FDA UDI

Identifiers

Primary DI / UDI-DI
00849044070576 FDA UDI
510(k) Number
K083416 FDA UDI
FDA Product Code
NKB FDA UDI
MNI FDA UDI
KWP FDA UDI
MNH FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 70 Millimeter FDA UDI
Outer Diameter — 8.5 Millimeter FDA UDI

Category: Trans-facet-screw internal spinal fixation system, sterile

Revolve by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

Cleared under the same submission

K083416 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Globus Medical, Inc.

Sources (1)

  • FDA UDI d10ca89e-1e84-4aa4-99e2-9a4cc51a16f8 36 fields · synced Jun 8, 2026