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Altus Spine HA Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Altus Spine

Identity

Trade Name
Altus Spine HA Pedicle Screw System FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Polyaxial Pedicle Screw, HA Coated. FDA UDI
Model / Reference
811-6555HA FDA UDI
Description
Polyaxial Pedicle Screw, HA Coated. FDA UDI

Identifiers

Primary DI / UDI-DI
00843210156958 FDA UDI
510(k) Number
K200922 FDA UDI
FDA Product Code
NKB FDA UDI
KWQ FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Spinal bone screw, non-bioabsorbable

Altus Spine HA Pedicle Screw System by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

Cleared under the same submission

K200922 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Altus Spine

Sources (1)

  • FDA UDI 1cd99548-6d21-4d0a-94e1-843971218e9e 34 fields · synced May 30, 2026