Skip to content

Pectus System Ps-0749

by Biomet Microfixation, Inc

Pectus System Ps-0749 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K061384 on 6 Jun 2006 and listed in FDA GUDID since 6 Oct 2015 (UDI-DI 00841036200763), 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) K061384

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 Number00841036200763 UDI-DI Date6 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK061384 Date6 Jun 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061384 decided 6 Jun 2006 Active
  • FDA GUDID UDI-DI 00841036200763 listed 6 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061384
  2. Listed FDA GUDID 00841036200763

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pectus System
Generic name
Funnel chest remodelling bar
Model / reference
PS-0749
Primary DI / UDI-DI
00841036200763
510(k) Number
FDA product code
HRS
GMDN term
Funnel chest remodelling bar
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Funnel chest remodelling bar

Cleared under the same submission (K061384)

and 8 more cleared under K061384

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

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