510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080997Substantially Equivalent

Ascension Pyrocarbon Lunate

Ascension Orthopedics, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080997 is the FDA 510(k) clearance record for ASCENSION PYROCARBON LUNATE, a class II device, cleared for Ascension Orthopedics, Inc. on under FDA product code KWN (Prosthesis, Wrist, Carpal Lunate). FDA records list 29 510(k) clearances for Ascension Orthopedics, Inc., from to . As of , FDA records show no recalls naming K080997.

Clearance record

Decision date
Received
(70 days to decision)
Product code
KWN Prosthesis, Wrist, Carpal Lunate
Regulation
21 CFR 888.3750
Device class
Class II
Review panel
Orthopedic
Applicant
Ascension Orthopedics, Inc. 8700 Cameron Rd., Suite 100, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWN

Trailing 12 months

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

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