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Reform Ti Modular

FDA UDI

Class II (US FDA UDI)

by Precision Spine, Inc.

Identity

Trade Name
Reform Ti Modular FDA UDI
Generic Name
Spinal bone screw head/rod adaptor FDA UDI
Device Name
Instrument Kit 1, Closed Tulip Compatible FDA UDI
Model / Reference
39-BK-0527 FDA UDI
Description
Instrument Kit 1, Closed Tulip Compatible FDA UDI

Identifiers

Catalog Number
39-BK-0527 FDA UDI
Primary DI / UDI-DI
00840019967563 FDA UDI
510(k) Number
K200303 FDA UDI
FDA Product Code
NKB FDA UDI
KWP 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
888.3050 FDA UDI
Commercial Distribution
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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal bone screw head/rod adaptor

Reform Ti Modular by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw head/rod adaptor.

Cleared under the same submission

K200303 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Spine, Inc.

Sources (1)

  • FDA UDI 7a6a9791-9864-49ba-8cd3-a47334a9e0e8 35 fields · synced May 30, 2026