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Permatage 10cc OS-PER-2001

by Abyrx, Inc.

Permatage 10cc OS-PER-2001 is a Class II device made by Abyrx, Inc., cleared under FDA 510(k) K241027 on 26 Sep 2024 and listed in FDA GUDID since 21 May 2025 (UDI-DI 00850391007450), 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) K241027

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 Number00850391007450 UDI-DI Date21 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241027 Date26 Sep 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241027 decided 26 Sep 2024 Active
  • FDA GUDID UDI-DI 00850391007450 listed 21 May 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241027
  2. Listed FDA GUDID 00850391007450

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Permatage 10cc
Generic name
Synthetic bone graft
Model / reference
OS-PER-2001
Primary DI / UDI-DI
00850391007450
510(k) Number
FDA product code
GXP
GMDN term
Synthetic bone graft
Device class
Class II
Regulation number
882.5300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Synthetic bone graft

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Other devices filed under Synthetic bone graft.

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Properties

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