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

Washer, Bolt, Nut, Non-Spinal, Metallic

21 CFR 888.3030 / Orthopedic
FDA source (opens on fda.gov)

NDG is the FDA product code for Washer, Bolt, Nut, Non-Spinal, Metallic, a class II device type, regulated under 21 CFR 888.3030. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
NDG
Device name
Washer, Bolt, Nut, Non-Spinal, Metallic
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code NDG

By decision year
1 clearance under product code NDG with a decision year between 2005 and 2005, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NDG by decision year
YearClearances
20051

Applicants with the most clearances

Product code NDG
Applicants holding the most 510(k) clearances under product code NDG
ApplicantClearances
Synthes (USA) Products LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order