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Stretto 1231.6700S

by Globus Medical, Inc.

Stretto 1231.6700S is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K231333 on 4 Aug 2023 and listed in FDA GUDID since 14 Aug 2026 (UDI-DI 00193982520502), 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) K231333

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 Number00193982520502 UDI-DI Date14 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231333 Date4 Aug 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231333 decided 4 Aug 2023 Active
  • FDA GUDID UDI-DI 00193982520502 listed 14 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231333
  2. Listed FDA GUDID 00193982520502

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stretto
Generic name
Orthopaedic bone cerclage cable
Model / Ref / Catalog
1231.6700S
Primary DI / UDI-DI
00193982520502
510(k) Number
FDA product code
HRS, HWC, JDQ
GMDN term
Orthopaedic bone cerclage cable
Device class
Class II
Regulation number
888.3030, 888.3040, 888.3010
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Related devices

Cleared under the same submission (K231333)

and 7 more cleared under K231333

Similar devices

Other devices filed under FDA product code HRS (Plate, fixation, bone).

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

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