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Secure-Loop 60 mm 102-4060

by Xiros Ltd

Secure-Loop 60 mm 102-4060 is a Class II device made by Xiros Ltd, cleared under FDA 510(k) K151601 on 9 Sep 2015 and listed in FDA GUDID since 28 May 2017 (UDI-DI 05060267131515), 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) K151601

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 Number05060267131515 UDI-DI Date28 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151601 Date9 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151601 decided 9 Sep 2015 Active
  • FDA GUDID UDI-DI 05060267131515 listed 28 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151601
  2. Listed FDA GUDID 05060267131515

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Secure-Loop 60 mm
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Model / Ref / Catalog
102-4060
Primary DI / UDI-DI
05060267131515
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
MRI safety
MR Conditional

Related devices

Category: Tendon/ligament bone anchor, non-bioabsorbable

Cleared under the same submission (K151601)

and 6 more cleared under K151601

Similar devices in this category

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

Other devices from Xiros Ltd

See all devices from Xiros Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)