Half Dome BD093013A

by Astura Medical

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841379157632 UDI-DI	Date19 May 2017Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Half Dome
Generic Name: Metallic spinal fusion cage, non-sterile
Model / Ref / Catalog: BD093013A

Primary DI / UDI-DI: 00841379157632
510(k) Number: K163481
FDA Product Code: MAX
GMDN Term: Metallic spinal fusion cage, non-sterile

Device Class: Class II
Regulation Number: 888.3080
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Width — 9 Millimeter
Length — 30 Millimeter
Height — 13 Millimeter
Angle — 0 degree

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Properties

Single Use
Prescription Use
Lot / Batch Number

Other properties (11)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No