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Lateral Dilator SR21-6000

by Surgentec LLC

Lateral Dilator SR21-6000 is a Class II device made by Surgentec LLC, cleared under FDA 510(k) K231831 on 3 Aug 2023 (1 earlier submission) and listed in FDA GUDID since 1 Nov 2024 (UDI-DI 00850040139884), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850040139884 UDI-DI Date1 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK231831 Date3 Aug 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231831 decided 3 Aug 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850040139884 listed 1 Nov 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230446
  2. Cleared FDA 510(k) K231831
  3. Listed FDA GUDID 00850040139884

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lateral Dilator
Generic name
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Model / reference
SR21-6000
Primary DI / UDI-DI
00850040139884
510(k) Number
FDA product code
OUR
GMDN term
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic fixation plate, bioabsorbable

Cleared under the same submission (K230446)

and 8 more cleared under K230446

Cleared under the same submission (K231831)

and 8 more cleared under K231831

Similar devices

Other devices filed under FDA product code OUR (Sacroiliac Joint Fixation).

Other devices from Surgentec LLC

See all devices from Surgentec LLC →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)