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Puma System Gen 3

by Panther Orthopedics, Inc.

Puma System Gen 3 is a Class II device made by Panther Orthopedics, Inc., cleared under FDA 510(k) K171703 on 1 Mar 2018 and listed in FDA GUDID since 13 Feb 2020 (UDI-DI B671FA0017B0), 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) K171703

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 NumberB671FA0017B0 UDI-DI Date13 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171703 Date1 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171703 decided 1 Mar 2018 Active
  • FDA GUDID UDI-DI B671FA0017B0 listed 13 Feb 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171703
  2. Listed FDA GUDID B671FA0017B0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Puma System
Generic name
Orthopaedic bone bolt
Model / reference
GEN 3
Primary DI / UDI-DI
B671FA0017B0
510(k) Number
FDA product code
HTN
GMDN term
Orthopaedic bone bolt
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic bone bolt

Similar devices

Also classified as Orthopaedic bone bolt.

Other devices from Panther Orthopedics, Inc.

  • PUMA System

    Class II

Properties

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