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Bioplate® 81-5738

by Bioplate, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM3848157380 UDI-DI Date9 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bioplate®
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Ref / Catalog
81-5738
Description
Access Burr Hole Cover - Low-Profile - 5 hole - 18 mm
Primary DI / UDI-DI
M3848157380
510(k) Number
FDA Product Code
JEY, HRS
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device Class
Class II
Regulation Number
872.4760, 888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 18 Millimeter

Related devices

Cleared under the same submission (K021684)

Other devices from Bioplate, Inc.

See all devices from Bioplate, Inc. →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: 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