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MSB/None 8437540

by Medtronic Sofamor Danek, Inc.

MSB/None 8437540 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K001532 on 16 Jun 2000 and listed in FDA GUDID since 19 Aug 2015 (UDI-DI 00673978950501), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K001532

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00673978950501 UDI-DI Date19 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK001532 Date16 Jun 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001532 decided 16 Jun 2000 Active
  • FDA GUDID UDI-DI 00673978950501 listed 19 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K001532
  2. Listed FDA GUDID 00673978950501

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MSB/None
Generic name
Spinal bone screw, non-bioabsorbable
Model / reference
8437540
Primary DI / UDI-DI
00673978950501
510(k) Number
FDA product code
MNH, MNI, KWP, KWQ
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3070, 888.3050, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K001532)

and 8 more cleared under K001532

Similar devices in this category

Other devices filed under Spinal bone screw, non-bioabsorbable.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)