Identity
- Trade Name
- LANCER FDA UDI
- Generic Name
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
- Device Name
- LANCER,SLIM COUNTER TORQUE FDA UDI
- Model / Reference
- M070-0162 FDA UDI
- Description
- LANCER,SLIM COUNTER TORQUE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996192873 FDA UDI
- 510(k) Number
- K171456 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Orthopaedic counter-torque/rod-pushing instrument
Lancer by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic counter-torque/rod-pushing instrument.
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- SPIRA®-A Integrated — CAMBER SPINE TECHNOLOGIES · Class I
- Mariner — SeaSpine Orthopedics Corporation · Class I
- General Instrument — ORTHOPEDIATRICS CORP. · Class I
- Malibu — SeaSpine Orthopedics Corporation · Class I
- Matrix — Synthes · Class I
Cleared under the same submission
K171456 also covers:
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER Pedicle Screw System — Choicespine, LP
- LANCER Pedicle Screw System — Choicespine, LP
- Lancer — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
- THUNDERBOLT — Choicespine, LP
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Choicespine, LP
Sources (1)
- FDA UDI b99ea328-ca50-4f1c-b743-f6bd4318af4c 34 fields · synced Jun 1, 2026