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Altus Spine HA Pedicle Screw System 811-8610HA

by Altus Spine

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 Number00843210157238 UDI-DI Date5 Apr 2023ListedStatusListed 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  • Withdrawn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
Altus Spine HA Pedicle Screw System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Reference
811-8610HA
Primary DI / UDI-DI
00843210157238
510(k) Number
FDA Product Code
NKB, KWQ
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3070, 888.3060
GUDID distribution status
In Commercial Distribution

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K200922)

Show all (12)

Other devices from Altus Spine

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No