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Precept

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
Precept FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
PRECEPT Loading Block, Leg FDA UDI
Model / Reference
8801346 FDA UDI
Description
PRECEPT Loading Block, Leg FDA UDI

Identifiers

Primary DI / UDI-DI
00887517401342 FDA UDI
510(k) Number
K143579 FDA UDI
FDA Product Code
KCT FDA UDI
GMDN Term
Internal spinal fixation procedure kit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, reusable

Precept by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Cleared under the same submission

K143579 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI 8533a1c5-b9b5-4056-aa52-e554e90fbc3b 35 fields · synced Jun 8, 2026