510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K004003Substantially Equivalent

Pro Osteon 200R with Calcium Sulfate, Models 2Rcs038, 2Rcs050, 2Rcs075, 2Rcs10, 2Rcs15, 2Rcs20, 2Rcs225, 2Rcs30

Interpore Cross Intl., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K004003 is the FDA 510(k) clearance record for PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30, a class II device, cleared for Interpore Cross Intl. on under FDA product code MQV (Filler, Bone Void, Calcium Compound). FDA records list 39 510(k) clearances for Interpore Cross Intl., from to . As of , FDA records show no recalls naming K004003.

Clearance record

Decision date
Received
(206 days to decision)
Product code
MQV Filler, Bone Void, Calcium Compound
Regulation
21 CFR 888.3045
Device class
Class II
Review panel
Orthopedic
Applicant
Interpore Cross Intl. 181 Technology Dr., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code MQV

Trailing 12 months
5 clearances under product code MQV in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260