510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K173693Substantially Equivalent

Orbitum Bone Staple Implant, X and VI

Orthovestments, LLC, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173693 is the FDA 510(k) clearance record for Orbitum Bone Staple Implant, X and VI, a class II device, cleared for Orthovestments, LLC on under FDA product code JDR (Staple, Fixation, Bone). FDA records list one 510(k) clearance for Orthovestments, LLC. As of , FDA records show no recalls naming K173693.

Clearance record

Decision date
Received
(84 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Orthovestments, LLC 1640 Powers Ferry Bldg. 9, Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDR

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