Identity
- Trade Name
- SURGICAL INSTRUMENT FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- DRIVE HANDPIECE IMPLANT CONE MORSE FDA UDI
- Model / Reference
- CCM 20 FDA UDI
- Description
- DRIVE HANDPIECE IMPLANT CONE MORSE FDA UDI
Identifiers
- Catalog Number
- CCM 20 FDA UDI
- Primary DI / UDI-DI
- 07899995203090 FDA UDI
- 510(k) Number
- K201688 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
Surgical Instrument by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
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Cleared under the same submission
K201688 also covers:
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
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
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (1)
- FDA UDI 7e9ceb89-1651-454c-8c4a-e8d3a347e422 35 fields · synced May 30, 2026