Identity
- Trade Name
- Actiflip FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- Actiflip w/ #2 Infinity Loop FDA UDI
- Model / Reference
- 11185SB FDA UDI
- Description
- Actiflip w/ #2 Infinity Loop FDA UDI
Identifiers
- Catalog Number
- 11185SB FDA UDI
- Primary DI / UDI-DI
- M68511185SB0 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 Conditional FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Actiflip by Parcus Medical 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
K152711 also covers:
- AcTiFlip — PARCUS MEDICAL LLC
- AcTiFlip — PARCUS MEDICAL LLC
- AcTiFlip — PARCUS MEDICAL LLC
- GFS Naked — PARCUS MEDICAL LLC
- GFS Naked — PARCUS MEDICAL LLC
- GFS Naked — PARCUS MEDICAL LLC
- GFS Naked — PARCUS MEDICAL LLC
- GFS Naked — PARCUS MEDICAL LLC
- GFS Naked — PARCUS MEDICAL LLC
- GFS Naked — PARCUS MEDICAL LLC
- GFS Naked — PARCUS MEDICAL LLC
- GFS Naked — PARCUS MEDICAL LLC
K202259 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Parcus Medical Llc
Sources (1)
- FDA UDI ce201092-ad56-4992-b311-30d9f0bc18a6 36 fields · synced May 31, 2026