Osteomed MSS

FDA 510(k) K961418 · Osteomed Corp.

Substantially Equivalent

510(k) numberK961418

Submission

Device name
Osteomed MSS
Applicant
Osteomed Corp.
Irving, TX, US
Received
April 12, 1996
Decision date
October 25, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DZL – Screw, Fixation, Intraosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4880
Specialty
Dental
Implant
Yes

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Questions and answers

When was Osteomed MSS cleared by the FDA?

Osteomed MSS (K961418) received a 510(k) decision of Substantially Equivalent on October 25, 1996, 196 days after the submission was received.

What is the product code of K961418?

The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.