510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982354Substantially Equivalent

Sd Trans-Osseous Fastener Models Tob 6 Bolt 32/50, Tob 6 Bolt 50/80, Tob 6 Bolt 80/140, Tob 6 Washer Models 12Mm 16Mm 1M

Special Devices, Inc., Grass Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982354 is the FDA 510(k) clearance record for SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M, a class II device, cleared for Special Devices, Inc. on under FDA product code HTN (Washer, Bolt Nut). FDA records list 2 510(k) clearances for Special Devices, Inc., from to . As of , FDA records show no recalls naming K982354.

Clearance record

Decision date
Received
(140 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Special Devices, Inc. 12493 Old Rough And Ready Hwy., Grass Valley CA
510(k) summary
Statement
Third party review
No

Clearances, product code HTN

Trailing 12 months
3 clearances under product code HTN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260