20-8000-000-11

by Orthosoft Inc

20-8000-000-11 is a Class II device made by Orthosoft Inc, cleared under FDA 510(k) K100599 on 5 Apr 2010 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00889024304253), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024304253 UDI-DI	Date12 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK100599	Date5 Apr 2010Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00889024304253
FDA 510(k) database 510(k) number K100599

Across registries

2 registries list this device

FDA 510(k) K100599 decided 5 Apr 2010 Active
FDA GUDID UDI-DI 00889024304253 listed 12 Sep 2016 Listed

Timeline

2 dated events

5 Apr 2010 Cleared FDA 510(k) K100599
12 Sep 2016 Listed FDA GUDID 00889024304253

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Orthopaedic bone pin, non-bioabsorbable
Model / Ref / Catalog: 20-8000-000-11

Primary DI / UDI-DI: 00889024304253
510(k) Number: K100599
FDA product code: OLO
GMDN term: Orthopaedic bone pin, non-bioabsorbable

Device class: Class II
Regulation number: 882.4560
GUDID distribution status: In Commercial Distribution

Size: Length — 80 Millimeter
Outer Diameter — 3.2 Millimeter

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9, all answered No)