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Dual Anchor Inserter with Bioabsorbable Anchors
FDA UDIClass II (US FDA UDI)
by Embody, Inc.
Identity
- Trade Name
- Dual Anchor Inserter with Bioabsorbable Anchors FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone dyed with D&C Violet No. 2. Two each of the Bioabsorbable Anchors are provided sterile for single-use only and are packaged preloaded in a single anchor inserter instrument, the Dual Anchor Inserter, in a dual sterile pouch configuration. FDA UDI
- Model / Reference
- TR-0001-21 FDA UDI
- Description
- The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone dyed with D&C Violet No. 2. Two each of the Bioabsorbable Anchors are provided sterile for single-use only and are packaged preloaded in a single anchor inserter instrument, the Dual Anchor Inserter, in a dual sterile pouch configuration. FDA UDI
Identifiers
- Catalog Number
- TR-0001-21 FDA UDI
- Primary DI / UDI-DI
- 00810063820152 FDA UDI
- 510(k) Number
- K213958 FDA UDI
- FDA Product Code
- MAI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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, bioabsorbableSoft-tissue/mesh anchor, bioabsorbable
Dual Anchor Inserter with Bioabsorbable Anchors by Embody, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue/mesh anchor, bioabsorbable.
- Mendit Reload Set — Escala Medical · Class II
- OPTIFIX — Davol Inc. · Class II
- Integrity Implant Fixation Kit — Anika Therapeutics, Inc. · Class II
- OPTIFIX — Davol Inc. · Class II
- Mendit Reload Set — Escala Medical · Class II
- Mendit Reload Set — Escala Medical · Class II
- OPTIFIX — Davol Inc. · Class II
- TissueTak™ — Via Surgical , Ltd. · Class II
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
- Embody, Inc.
Sources (1)
- FDA UDI 606645d0-77d2-4af0-a133-91771865902b 35 fields · synced May 30, 2026