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Transcend Nanotec 101-Pro-13184010-S

by Alphatec Spine, 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 Number00190376334974 UDI-DI Date29 Dec 2021ListedStatusListed 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  • Withdrawn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
Transcend Nanotec
Generic Name
Polymeric spinal interbody fusion cage
Model / Reference
101-PRO-13184010-S
Primary DI / UDI-DI
00190376334974
510(k) Number
FDA Product Code
OVD, MAX, PHM
GMDN Term
Polymeric spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Size
Width — 18 Millimeter
Angle — 10 degree
Height — 13 Millimeter
Length — 40 Millimeter

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K211805)

Show all (12)

Other devices from Alphatec Spine, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No