510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K895157Substantially Equivalent

S.a.f. Acetabular Cup

Synergy Orthopaedics Intl., Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895157 is the FDA 510(k) clearance record for S.A.F. ACETABULAR CUP, a class III device, cleared for Synergy Orthopaedics Intl., Inc. on under FDA product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)). FDA records list 2 510(k) clearances for Synergy Orthopaedics Intl., Inc., from to . As of , FDA records show no recalls naming K895157.

Clearance record

Decision date
Received
(113 days to decision)
Product code
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation
21 CFR 888.3330
Device class
Class III
Review panel
Orthopedic
Applicant
Synergy Orthopaedics Intl., Inc. 5780 W. 71st St., Indianapolis IN
Third party review
No

Clearances, product code KWA

Trailing 12 months

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

FDA records show no clearances under product code KWA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWA, 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