510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051256Substantially Equivalent

Silverseal Orthotic Component with X-Static

Noble Fiber Technologies, Inc., Clarks Summit PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051256 is the FDA 510(k) clearance record for SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC, a class I device, cleared for Noble Fiber Technologies, Inc. on under FDA product code ISH (Component, External, Limb, Ankle/Foot). FDA records list 8 510(k) clearances for Noble Fiber Technologies, Inc., from to . As of , FDA records show no recalls naming K051256.

Clearance record

Decision date
Received
(66 days to decision)
Product code
ISH Component, External, Limb, Ankle/Foot
Regulation
21 CFR 890.3420
Device class
Class I
Review panel
Physical Medicine
Applicant
Noble Fiber Technologies, Inc. 421 S. State St., Clarks Summit PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ISH

Trailing 12 months

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

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