Tightrope Acromioclavicular (Ac) Device, Titanium, Stainless Steel , Models AR-2257, Ar-Tbd
FDA 510(k) K052776 · Arthrex, Inc.
510(k) numberK052776
Submission
- Device name
- Tightrope Acromioclavicular (Ac) Device, Titanium, Stainless Steel , Models AR-2257, Ar-Tbd
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- October 3, 2005
- Decision date
- December 13, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Tightrope Acromioclavicular (Ac) Device, Titanium, Stainless Steel , Models AR-2257, Ar-Tbd cleared by the FDA?
Tightrope Acromioclavicular (Ac) Device, Titanium, Stainless Steel , Models AR-2257, Ar-Tbd (K052776) received a 510(k) decision of Substantially Equivalent on December 13, 2005, 71 days after the submission was received.
What is the product code of K052776?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.