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Primus 66027-045

by Spinal Elements, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840466901011 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Primus
Generic Name
Bone-screw internal spinal fixation system rod
Model / Reference
66027-045
Primary DI / UDI-DI
00840466901011
510(k) Number
FDA Product Code
NKB, KWP, KWQ, OLO
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class II
Regulation Number
888.3070, 888.3050, 888.3060, 882.4560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K243916)

Show all (12)

Other devices from Spinal Elements, Inc.

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

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