Identity
- Trade Name
- SAMPEDRO FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- 3.5mm Self Tapping Locking Screw, Pentalock, 34mm FDA UDI
- Model / Reference
- 0 FDA UDI
- Description
- 3.5mm Self Tapping Locking Screw, Pentalock, 34mm FDA UDI
Identifiers
- Catalog Number
- TBPA3534 FDA UDI
- Primary DI / UDI-DI
- 07708604560120 FDA UDI
- 510(k) Number
- K220199 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Sampedro by Industrias Medicas Sampedro S.A.S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Cleared under the same submission
K220199 also covers:
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
- SAMPEDRO — Industrias Medicas Sampedro S.A.S
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
- Industrias Medicas Sampedro S.A.S
Sources (1)
- FDA UDI f85e1515-1b88-437b-bccf-0a13350eca5c 35 fields · synced May 30, 2026