Identity
- Trade Name
- Mendit Retriever Set FDA UDI
- Generic Name
- Soft-tissue/mesh anchor, bioabsorbable FDA UDI
- Device Name
- Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly. FDA UDI
- Model / Reference
- Mendit Retriever Set - permanent suture (ePTFE 2-0) FDA UDI
- Description
- Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional. The Retriever Cartridge operated by the Handle (forming the “Retriever”) is used to retrieve the anchor-suture assembly after it has been placed on ligament. Retrieval of the Implant may be followed by the placement of a new anchor-suture assembly. FDA UDI
Identifiers
- Catalog Number
- ES0512 FDA UDI
- Primary DI / UDI-DI
- 07290019174196 FDA UDI
- 510(k) Number
- K213783 FDA UDI
- FDA Product Code
- PBQ FDA UDI
- GMDN Term
- Soft-tissue/mesh anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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: Soft-tissue/mesh anchor, bioabsorbable
Mendit Retriever Set by Escala Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue/mesh anchor, bioabsorbable.
- OPTIFIX — Davol Inc. · Class II
- Integrity Implant Fixation Kit — Anika Therapeutics, Inc. · Class II
- OPTIFIX — Davol Inc. · Class II
- OPTIFIX — Davol Inc. · Class II
- TissueTak™ — Via Surgical , Ltd. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- FasTouch™ Absorbable — Via Surgical , Ltd. · Class II
- SORBAFIX — Davol Inc. · Class II
Cleared under the same submission
K213783 also covers:
- APYX Applicator Set — Escala Medical
- APYX Retriever Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
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
- Escala Medical
Sources (1)
- FDA UDI cc8eb0e3-39d6-47d3-bdfe-ff97ac37bf0f 36 fields · synced Jun 8, 2026