Identity
- Trade Name
- Agile Suture Anchor FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- Agile Suture Anchor, 2.5mm diameter with one #2 HS Fiber Suture FDA UDI
- Model / Reference
- 285945 FDA UDI
- Description
- Agile Suture Anchor, 2.5mm diameter with one #2 HS Fiber Suture FDA UDI
Identifiers
- Catalog Number
- 285945 FDA UDI
- Primary DI / UDI-DI
- 00811714036335 FDA UDI
- 510(k) Number
- K180951 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
Agile Suture Anchor by Responsive Orthopedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180951 also covers:
- Harrier — RESPONSIVE ORTHOPEDICS LLC
- Harrier — RESPONSIVE ORTHOPEDICS LLC
- Hornet — RESPONSIVE ORTHOPEDICS LLC
- Hornet — RESPONSIVE ORTHOPEDICS LLC
- Hornet — RESPONSIVE ORTHOPEDICS LLC
- Hornet — RESPONSIVE ORTHOPEDICS LLC
- Hornet — RESPONSIVE ORTHOPEDICS LLC
- Lightning — RESPONSIVE ORTHOPEDICS LLC
- Lightning — RESPONSIVE ORTHOPEDICS LLC
- Lightning — RESPONSIVE ORTHOPEDICS LLC
- Lightning — RESPONSIVE ORTHOPEDICS LLC
- Lightning — 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 |
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Manufacturer
- Manufacturer
- Responsive Orthopedics Llc
Sources (1)
- FDA UDI 01538cea-c6f8-4203-81b2-16d950b31c6e 35 fields · synced May 30, 2026