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mBôs (Monogram mBôs TKA System)

Monogram Orthopaedics, Inc.

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

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Company

Monogram Orthopaedics, Inc.
United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

0
Cited in this 510(k)

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K242121
Device name
mBôs (Monogram mBôs TKA System)
Company
Monogram Orthopaedics, Inc.
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2024-07-19
Decision date
2025-03-14
Submission type
Traditional

Intended Use

)
to legally marketed

Summary parsed at:2026-06-19 05:13:58 UTC

Predicate devices

0

No predicate K numbers were extracted

The Summary PDF may not be parsed yet, or this submission may not cite predicate devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K242121 as a predicate