Skip to content

STRETTO™ Cable System

by Globus Medical, Inc.

510(k) K231333

STRETTO™ Cable System is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K231333 on 4 Aug 2023, active as of 25 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231333 Date4 Aug 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JDQ
Device class
Class II
Regulation
21 CFR Part 888.3010
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K231333

12 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K231333
UDI-DISize and differences
STRETTO 1231.6340S
GLOBUS MEDICAL, INC.
1231.6340S / 1231.6340S00193982520519
Single use: yes
On the market
STRETTO 1231.6440S
GLOBUS MEDICAL, INC.
1231.6440S / 1231.6440S00193982520526
Single use: yes
On the market
STRETTO 1231.6700S
GLOBUS MEDICAL, INC.
1231.6700S / 1231.6700S00193982520502
Single use: yes
On the market
STRETTO 2231.6340S
GLOBUS MEDICAL, INC.
2231.6340S / 2231.6340S00193982520540
Single use: yes
On the market
STRETTO 2231.6440S
GLOBUS MEDICAL, INC.
2231.6440S / 2231.6440S00193982520533
Single use: yes
On the market
STRETTO 2231.6700S
GLOBUS MEDICAL, INC.
2231.6700S / 2231.6700S00193982520557
Single use: yes
On the market
STRETTO 2231.9177S
GLOBUS MEDICAL, INC.
2231.9177S / 2231.9177S00193982520564
Single use: yes
On the market
STRETTO 6231.8001
GLOBUS MEDICAL, INC.
6231.800100193982511203
Single use: no
On the market
STRETTO 6231.8003
GLOBUS MEDICAL, INC.
6231.800300193982513962
Single use: no
On the market
STRETTO 6231.8010
GLOBUS MEDICAL, INC.
6231.801000193982511210
Single use: no
On the market
STRETTO 6231.8200
GLOBUS MEDICAL, INC.
6231.820000193982511227
Single use: no
On the market
STRETTO 7231.9177S
GLOBUS MEDICAL, INC.
7231.9177S / 7231.9177S00193982520571
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code JDQ (Cerclage, Fixation).

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →