Identity
- Trade Name
- EIT ALIF Distractor Forceps FDA UDI
- Generic Name
- Bone distraction forceps FDA UDI
- Device Name
- Offset Distractor Forceps FDA UDI
- Model / Reference
- AFT10100 FDA UDI
- Description
- Offset Distractor Forceps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260557774694 FDA UDI
- 510(k) Number
- K170503 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone distraction forceps 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Bone distraction forceps
EIT ALIF Distractor Forceps by EIT Emerging Implant Technologies GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone distraction forceps.
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Cleared under the same submission
K170503 also covers:
- EIT ALIF Paddle Distractor — EIT Emerging Implant Technologies GmbH
- EIT ALIF Paddle Distractor — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
- EIT ALIF Trial — EIT Emerging Implant Technologies GmbH
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 |
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Manufacturer
- Manufacturer
- EIT Emerging Implant Technologies GmbH
Sources (1)
- FDA UDI 441c1e30-2a3e-4772-bdb2-5248f6bce3ae 34 fields · synced Jun 6, 2026