Identity
- Trade Name
- Constrictor® Mini Button Extender FDA UDI
- Generic Name
- Orthopaedic bone washer, sterile FDA UDI
- Device Name
- Mini Extended Button to be used with Constrictor® Mini (AB-3000) FDA UDI
- Model / Reference
- AB-3150 FDA UDI
- Description
- Mini Extended Button to be used with Constrictor® Mini (AB-3000) FDA UDI
Identifiers
- Catalog Number
- AB-3150 FDA UDI
- Primary DI / UDI-DI
- 00854629006758 FDA UDI
- 510(k) Number
- K191319 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Orthopaedic bone washer, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone washer, sterile
Constrictor® Mini Button Extender by Dunamis Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone washer, sterile.
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- RONDO' — Citieffe · Class II
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Cleared under the same submission
K191319 also covers:
- CMC Guide — Dunamis Medical LLC
- CMC Spacer — Dunamis Medical LLC
- Constrictor - Syndesmosis Knotless Adjustable Button System — Dunamis Medical LLC
- Constrictor - Syndesmosis Repair (Stainless Steel) — Dunamis Medical LLC
- Constrictor® Button Extender — Dunamis Medical LLC
- Constrictor® Link — Dunamis Medical LLC
- Constrictor® Link (AC) — Dunamis Medical LLC
- Constrictor® Mini Button Extender — Dunamis Medical LLC
- Constrictor® Mini Snare — Dunamis Medical LLC
- Constrictor® Mini for Syndesmosis Repair — Dunamis Medical LLC
- Fixation Button-Oblong — Dunamis Medical LLC
- Hallux Guide — Dunamis Medical LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dunamis Medical LLC
Sources (1)
- FDA UDI 570812db-9a02-4a0a-87d1-1f9d00874297 35 fields · synced May 30, 2026