Identity
- Trade Name
- Hercules FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- Hercules™ FT Suture Anchor, 3.5 mm x 10.5 mm with two #0 BightForce Suture and tapered 1/2 circle needles FDA UDI
- Model / Reference
- A20 SP235 FDA UDI
- Description
- Hercules™ FT Suture Anchor, 3.5 mm x 10.5 mm with two #0 BightForce Suture and tapered 1/2 circle needles FDA UDI
Identifiers
- Catalog Number
- A20 SP235 FDA UDI
- Primary DI / UDI-DI
- 00810021860220 FDA UDI
- 510(k) Number
- K201636 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
No
FDA UDI
MR Safe FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Hercules by In2Bones, USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K201636 also covers:
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
- In2Bones, USA
Sources (1)
- FDA UDI b330e505-5067-40ab-a774-950649df1758 36 fields · synced Jun 1, 2026