510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161548Substantially Equivalent

Osseointegrated Fixtures

Southern Implants, (Pty.) Ltd., Irene, ZA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161548 is the FDA 510(k) clearance record for Osseointegrated Fixtures, a class II device, cleared for Southern Implants (Pty), Ltd. on under FDA product code FZE (Prosthesis, Nose, Internal). FDA records list 24 510(k) clearances for Southern Implants (Pty), Ltd., from to . As of , FDA records show no recalls naming K161548.

Clearance record

Decision date
Received
(181 days to decision)
Product code
FZE Prosthesis, Nose, Internal
Regulation
21 CFR 878.3680
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Southern Implants (Pty), Ltd. 1 Albert St., Irene, ZA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FZE

Trailing 12 months

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

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