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PressON™

FDA UDI

Class II (US FDA UDI)

by Nexus Spine, L.l.c.

Identity

Trade Name
PressON™ FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Lat Bld, Interlagos 25x60mm, HC FDA UDI
Model / Reference
820322.05 FDA UDI
Description
Lat Bld, Interlagos 25x60mm, HC FDA UDI

Identifiers

Primary DI / UDI-DI
B678820322050 FDA UDI
510(k) Number
K133287 FDA UDI
K160820 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
NKB FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Width — 25 Millimeter FDA UDI
Length — 60 Millimeter FDA UDI

PressON™ by Nexus Spine, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K133287 also covers:

K160820 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nexus Spine, L.l.c.

Sources (1)

  • FDA UDI d94ce7c1-2a5b-47e8-b841-3a39c62a81ae 36 fields · synced Jun 8, 2026