Skip to content

Abyrx Spatula OS-SPA

by Abyrx, Inc.

Abyrx Spatula OS-SPA is a device classified as Unclassified made by Abyrx, Inc., cleared under FDA 510(k) K113627 on 17 Feb 2012 and listed in FDA GUDID since 24 Jan 2017 (UDI-DI 00850391007146), 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) K113627

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 Number00850391007146 UDI-DI Date24 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK113627 Date17 Feb 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113627 decided 17 Feb 2012 Active
  • FDA GUDID UDI-DI 00850391007146 listed 24 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113627
  2. Listed FDA GUDID 00850391007146

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Abyrx Spatula
Generic name
Bone wax, synthetic
Model / reference
OS-SPA
Primary DI / UDI-DI
00850391007146
510(k) Number
FDA product code
MTJ
GMDN term
Bone wax, synthetic
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone wax, synthetic

Cleared under the same submission (K113627)

Similar devices

Other devices filed under FDA product code MTJ (Wax,Bone).

Other devices from Abyrx, Inc.

See all devices from Abyrx, Inc. →

Properties

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