Identity
- Trade Name
- TiLock2 Pedicle Screw System FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- 4-Sided Fixed Handle FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 4-Sided Fixed Handle FDA UDI
Identifiers
- Catalog Number
- GL322 FDA UDI
- Primary DI / UDI-DI
- M719GL3220 FDA UDI
- 510(k) Number
- K171838 FDA UDI
- FDA Product Code
- NKB FDA UDIKWP FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument handle, non-torque-limiting
TiLock2 Pedicle Screw System by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument handle, non-torque-limiting.
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- Fusion Taper Remover Screw Grip — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- IDOL — İDOL HASTANE ÜRÜN. SAN. VE TİC. A.Ş. · Class I
- Tecomet — Tecomet,Inc · Class I
- Equinoxe — Exactech, Inc. · Class II
- Kinectiv® — Zimmer, Inc. · Class I
- CUSTOM U JOINT DRIVER — Zimmer, Inc. · Class I
Cleared under the same submission
K171838 also covers:
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock — Genesys Orthopedics Systems LLC
- TiLock2 Pedicle Screw System — Genesys Orthopedics Systems LLC
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
- Genesys Orthopedics Systems LLC
Sources (1)
- FDA UDI 28b5876f-f2db-4e13-a9fd-6348a132f3d0 36 fields · synced May 30, 2026