Skip to content

Revolve 185.370

by Globus Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00849044070712 UDI-DI Date5 Nov 2015ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Revolve
Generic Name
Trans-facet-screw internal spinal fixation system, sterile
Model / Reference
185.370
Primary DI / UDI-DI
00849044070712
510(k) Number
FDA Product Code
MNH, NKB, KWP, MNI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile
Device Class
Class II
Regulation Number
888.3070, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 170 Millimeter

Related devices

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

Cleared under the same submission (K083416)

Show all (12)

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No