510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103228Substantially Equivalent

Paramount R Ibf Device

Theken Companies LLC, Akron OH / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103228 is the FDA 510(k) clearance record for PARAMOUNT R IBF DEVICE, a class II device, cleared for Theken Spine, LLC on under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar). FDA's definition for product code MAX reads: "Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". FDA records list 28 510(k) clearances for THEKEN COMPANIES, LLC, from to . As of , FDA records show no recalls naming K103228.

Clearance record

Decision date
Received
(64 days to decision)
Product code
MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Theken Spine, LLC 1800 Triplett Blvd., Akron OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAX

Trailing 12 months
19 clearances under product code MAX in the twelve months to October 2026, May 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code MAX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20262
February 20263
March 20260
April 20261
May 20265
June 20261
July 20264
August 20261
September 20260
October 20260