Identity
- Trade Name
- ZAVATION MODULAR MIS HEAD ASSEMBLY FDA UDI
- Generic Name
- Spinal bone screw head/rod adaptor FDA UDI
- Device Name
- MODULAR MIS HEAD ASSEMBLY - 15MM REDUCTION FDA UDI
- Model / Reference
- 982-2015 FDA UDI
- Description
- MODULAR MIS HEAD ASSEMBLY - 15MM REDUCTION FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00197157069612 FDA UDI
- 510(k) Number
- K243908 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal bone screw head/rod adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Spinal bone screw head/rod adaptor
Zavation Modular Mis Head Assembly by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw head/rod adaptor.
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- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- TAURUS — CTL Medical Corporation · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- DIPLOMAT — SIGNUS Medizintechnik GmbH · Class II
- Vertefix — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
Cleared under the same submission
K243908 also covers:
- ZAVAATION SCREWDRIVER — ZAVATION
- ZAVATION — ZAVATION
- ZAVATION CADDY — ZAVATION
- ZAVATION CADDY — ZAVATION
- ZAVATION CADDY — ZAVATION
- ZAVATION CADDY — ZAVATION
- ZAVATION CADDY LID — ZAVATION
- ZAVATION COMPRESSOR — ZAVATION
- ZAVATION COUNTER TORQUE WRENCH — ZAVATION
- ZAVATION DILATION TUBE — ZAVATION
- ZAVATION DRIVER — ZAVATION
- ZAVATION DRIVER — ZAVATION
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
- Zavation
Sources (1)
- FDA UDI 9ab299de-2e0f-4938-9ac4-74ec8dc4d385 35 fields · synced May 30, 2026