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Sterile Posterior Spinal Fixation System SB211-34090

by Shanghai Reach Medical Instrument Co., Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06941312465382 UDI-DI Date13 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sterile Posterior Spinal Fixation System
Generic Name
Bone-screw internal spinal fixation system rod
Model / Reference
SB211-34090
Primary DI / UDI-DI
06941312465382
510(k) Number
FDA Product Code
NKB
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K221745)

Show all (12)

Other devices from Shanghai Reach Medical Instrument Co., Ltd

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Properties

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

Other properties (7)

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