510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202338Substantially Equivalent

SpaceFlex Shoulder

G21, S.r.l., San Possidonio, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202338 is the FDA 510(k) clearance record for SpaceFlex Shoulder, a class II device, cleared for G21, S.R.L. on under FDA product code MBB (Bone Cement, Antibiotic). FDA records list 9 510(k) clearances for G21, S.R.L., from to . As of , FDA records show no recalls naming K202338.

Clearance record

Decision date
Received
(184 days to decision)
Product code
MBB Bone Cement, Antibiotic
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
G21, S.r.l. Via Sandro Pertini, 8, San Possidonio, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBB

Trailing 12 months

FDA records hold no clearances under product code MBB in the trailing twelve months.

FDA records show no clearances under product code MBB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MBB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260