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Panama™

by Flospine 121 variants

Panama™ (08-0145-016) is a Class II device made by Flospine, cleared under FDA 510(k) K210182 on 7 Apr 2021 and listed in FDA GUDID since 26 Aug 2021 (UDI-DI B1830801450160), 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) K210182

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 NumberB1830801450160 UDI-DI Date26 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210182 Date7 Apr 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210182 decided 7 Apr 2021 Active
  • FDA GUDID UDI-DI B1830801450160 listed 26 Aug 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210182
  2. Listed FDA GUDID B1830801450160

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Spinal fixation plate, non-bioabsorbable
Model / Ref / Catalog
Panama™, 08-0145-016
Primary DI / UDI-DI
B1830801450160
510(k) Number
FDA product code
KWQ
GMDN term
Spinal fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal fixation plate, non-bioabsorbable

Cleared under the same submission (K210182)

and 8 more cleared under K210182

Similar devices

Other devices filed under FDA product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

Other devices from Flospine

  • Canaveral®

    Class II

  • Ti-Largo™

    Class II

  • Panama™

    Class II

  • Canaveral®

    Class II

See all devices from Flospine →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)