Identity
- Trade Name
- Tyber Medical FDA UDI
- Generic Name
- Intervertebral-body internal spinal fixation system FDA UDI
- Model / Reference
- Fixed Screws 4.00 mm OD x 16 mm FDA UDI
Identifiers
- Catalog Number
- 204054116SM FDA UDI
- Primary DI / UDI-DI
- M695204054116SM2Q FDA UDI
- 510(k) Number
- K103068 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Intervertebral-body internal spinal fixation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intervertebral-body internal spinal fixation system
Tyber Medical by Tyber Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103068 also covers:
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE LLC
- King Cobra — EMINENT SPINE 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
- Tyber Medical
Sources (1)
- FDA UDI b5aba06c-e0a6-482d-ab24-891d99e0654f 34 fields · synced Jun 8, 2026