n/a 665-3130

by Ortho Development Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00822409068456 UDI-DI	Date10 Aug 2020Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Bone-resection orthopaedic reamer, reusable
Model / Reference: 665-3130

Primary DI / UDI-DI: 00822409068456
FDA Product Code: HTO
GMDN Term: Bone-resection orthopaedic reamer, reusable

Device Class: Class I
Regulation Number: 888.4540
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Outer Diameter — 13 Millimeter

Other devices from Ortho Development Corp.

N/A 228-0031

Class I
N/A 233-0138

Class I
N/A 233-0139

Class I
N/A 233-0140

Class I
N/A 233-0142

Class I
N/A 233-0141

Class I

See all devices from Ortho Development Corp. →

Properties

Premarket Exempt
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No