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Scorpio 82-6-0718

by Howmedica Osteonics Corp.

Scorpio 82-6-0718 is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K071991 on 15 Aug 2007 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613327030624), 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) K071991

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 Number07613327030624 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK071991 Date15 Aug 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071991 decided 15 Aug 2007 Active
  • FDA GUDID UDI-DI 07613327030624 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K071991
  2. Listed FDA GUDID 07613327030624

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Scorpio
Generic name
Tibial insert
Model / Ref / Catalog
82-6-0718
Primary DI / UDI-DI
07613327030624
510(k) Number
FDA product code
JWH
GMDN term
Tibial insert
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tibial insert

Cleared under the same submission (K071991)

and 8 more cleared under K071991

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

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