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MSB/None 8436550

by Medtronic Sofamor Danek, Inc.

MSB/None 8436550 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 00673978950372), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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 Number00673978950372 UDI-DI Date19 Aug 2015ListedStatusListed GUDID: not 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 00673978950372 listed 19 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K001532
  2. Listed FDA GUDID 00673978950372

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  • Withdrawn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
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / reference
8436550
Primary DI / UDI-DI
00673978950372
510(k) Number
FDA product code
KWP, MNI, KWQ, MNH
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
888.3050, 888.3070, 888.3060
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K001532)

and 8 more cleared under K001532

Similar devices

Other devices filed under FDA product code KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

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