510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992970Substantially Equivalent

Digit Widget

Hand Biomechanics Lab Inc, Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992970 is the FDA 510(k) clearance record for DIGIT WIDGET, a class II device, cleared for Hand Biomechanics Lab, Inc. on under FDA product code JDW (Pin, Fixation, Threaded). FDA records list 9 510(k) clearances for Hand Biomechanics Lab, Inc., from to . As of , FDA records show no recalls naming K992970.

Clearance record

Decision date
Received
(66 days to decision)
Product code
JDW Pin, Fixation, Threaded
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Hand Biomechanics Lab, Inc. 77 Scripps Dr., Suite 104, Sacramento CA
510(k) summary
Summary
Third party review
No

Clearances, product code JDW

Trailing 12 months
1 clearance under product code JDW 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 JDW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260