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MBlock Adjustable Loop XL

by S.B.M 2 variants

MBlock Adjustable Loop XL (05.05.0088) is a Class II device made by S.B.M, cleared under FDA 510(k) K151004 on 17 Nov 2015 and listed in FDA GUDID since 14 Jun 2021 (UDI-DI 03760304680168), active as of 23 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 23 Oct 2026

Documents

510(k) K151004

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760304680168 UDI-DI Date14 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151004 Date17 Nov 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151004 decided 17 Nov 2015 Active
  • FDA GUDID UDI-DI 03760304680168 listed 14 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151004
  2. Listed FDA GUDID 03760304680168

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MBlock
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Model / Ref / Catalog
Adjustable Loop XL, 05.05.0088
Primary DI / UDI-DI
03760304680168
510(k) Number
FDA product code
MBI
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tendon/ligament bone anchor, non-bioabsorbable

Cleared under the same submission (K151004)

and 5 more cleared under K151004

Similar devices in this category

Other devices filed under Tendon/ligament bone anchor, non-bioabsorbable.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)