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SacroFuse 01-42201-35

by Spinefrontier, Inc.

SacroFuse 01-42201-35 is a Class II device made by Spinefrontier, Inc., cleared under FDA 510(k) K150017 on 24 Apr 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00190361035947), 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) K150017

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 Number00190361035947 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150017 Date24 Apr 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150017 decided 24 Apr 2015 Active
  • FDA GUDID UDI-DI 00190361035947 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150017
  2. Listed FDA GUDID 00190361035947

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SacroFuse
Generic name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Model / reference
01-42201-35
Primary DI / UDI-DI
00190361035947
510(k) Number
FDA product code
OUR
GMDN term
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 10 Millimeter
Length — 35 Millimeter

Related devices

Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

Cleared under the same submission (K150017)

and 8 more cleared under K150017

Similar devices

Other devices filed under FDA product code OUR (Sacroiliac joint fixation).

Other devices from Spinefrontier, Inc.

See all devices from Spinefrontier, Inc. →

Properties

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