Identity
- Trade Name
- TRUESPAN ORTHOCORD FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- TRUESPAN Meniscal Repair System PEEK 12 DEGREES ORTHOCORD Violet braided composite suture Size 2-0, (2) PEEK Backstops, and (1) Applier with 12 DEGREES needle Depth Stop: 10mm-20mm Plus or Minus 1mm; Needle: 10mm Plus or Minus .13mm FDA UDI
- Model / Reference
- 228151 FDA UDI
- Description
- TRUESPAN Meniscal Repair System PEEK 12 DEGREES ORTHOCORD Violet braided composite suture Size 2-0, (2) PEEK Backstops, and (1) Applier with 12 DEGREES needle Depth Stop: 10mm-20mm Plus or Minus 1mm; Needle: 10mm Plus or Minus .13mm FDA UDI
Identifiers
- Catalog Number
- 228151 FDA UDI
- Primary DI / UDI-DI
- 10886705026012 FDA UDI
- 510(k) Number
- K153667 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, 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, bioabsorbable
Truespan Orthocord by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, bioabsorbable.
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- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- 5 x 15mm CitreLock Implant — ACUITIVE TECHNOLOGIES · Class II
- Fix2Lock — OSTEONIC CO., Ltd. · Class II
- Fixone Hybrid Anchor — AJU PHARM. CO., LTD. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Twist — PARCUS MEDICAL LLC · Class II
Cleared under the same submission
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
- Medos International Sàrl
Sources (1)
- FDA UDI 257274aa-1ffe-4941-91b1-34096be9067c 37 fields · synced May 31, 2026