510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971332Substantially Equivalent

Ams Mainstay Urologic Bone Anchor

American Medical Systems, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971332 is the FDA 510(k) clearance record for AMS MAINSTAY UROLOGIC BONE ANCHOR, a class II device, cleared for American Medical Systems, Inc. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 82 510(k) clearances for American Medical Systems, Inc., from to . As of , FDA records show no recalls naming K971332.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
American Medical Systems, Inc. 10700 Bren Rd. W., Minnetonka MN
510(k) summary
Summary
Third party review
No

Clearances, product code MBI

Trailing 12 months
32 clearances under product code MBI in the twelve months to November 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20262
November 20260