Identity
- Trade Name
- Mustang Suture Anchor FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- Mustang Suture Anchor, 4.5mm with one suture tape FDA UDI
- Model / Reference
- 916000-4500 FDA UDI
- Description
- Mustang Suture Anchor, 4.5mm with one suture tape FDA UDI
Identifiers
- Catalog Number
- 916000-4500 FDA UDI
- Primary DI / UDI-DI
- 00811714035598 FDA UDI
- 510(k) Number
- K222763 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Mustang Suture Anchor by Responsive Orthopedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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Cleared under the same submission
K222763 also covers:
- Mustang Knotless Suture Anchor — RESPONSIVE ORTHOPEDICS LLC
- Mustang Knotless Suture Anchor — RESPONSIVE ORTHOPEDICS LLC
- Mustang Knotless Vented Suture Anchor — RESPONSIVE ORTHOPEDICS LLC
- Mustang Knotless Vented Suture Anchor — RESPONSIVE ORTHOPEDICS LLC
- Mustang Suture Anchor — RESPONSIVE ORTHOPEDICS LLC
- Mustang Suture Anchor — RESPONSIVE ORTHOPEDICS LLC
- Mustang Suture Anchor — RESPONSIVE ORTHOPEDICS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Responsive Orthopedics Llc
Sources (1)
- FDA UDI 46aea417-42f0-4b36-8e29-b7c59a9d79f4 35 fields · synced May 30, 2026