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Transcend NanoTec 310-PRO-08201610-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 Number00190376655789 UDI-DI Date14 Aug 2025ListedStatusListed 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  • Withdrawn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
310-PRO-08201610-S
Primary DI / UDI-DI
00190376655789
510(k) Number
FDA product code
ODP
GMDN term
Polymeric spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Size
Depth — 16 Millimeter
Height — 8 Millimeter
Width — 20 Millimeter
Angle — 10 degree

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K241375)

Show all (12)

Other devices from Alphatec Spine, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No