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InCompass® 2105-8530

by Zimmer Spine, Inc.

InCompass® 2105-8530 is a Class II device made by Zimmer Spine, Inc., listed in FDA GUDID since 24 Sep 2015 (UDI-DI 00889024401891), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024401891 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
InCompass®
Generic name
Bone-screw internal spinal fixation system, non-sterile
Model / Ref / Catalog
2105-8530
Primary DI / UDI-DI
00889024401891
FDA product code
MNI, KWQ, KWP, MNH
GMDN term
Bone-screw internal spinal fixation system, non-sterile
Device class
Class II
Regulation number
888.3070, 888.3060, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 8.5 Millimeter
Length — 30 Millimeter

Related devices

Category: Bone-screw internal spinal fixation system, non-sterile

Similar devices

Other devices filed under FDA product code MNI (ORTHOSIS, SPINAL PEDICLE FIXATION).

Other devices from Zimmer Spine, Inc.

See all devices from Zimmer Spine, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)