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Mectalif Posterior 03.27.040

by Medacta International SA

Mectalif Posterior 03.27.040 is a Class II device made by Medacta International SA, cleared under FDA 510(k) K133192 on 30 Jan 2014 and listed in FDA GUDID since 18 Nov 2014 (UDI-DI 07630030831829), active as of 12 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

510(k) K133192

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07630030831829 UDI-DI Date18 Nov 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133192 Date30 Jan 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133192 decided 30 Jan 2014 Active
  • FDA GUDID UDI-DI 07630030831829 listed 18 Nov 2014 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133192
  2. Listed FDA GUDID 07630030831829

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mectalif Posterior
Generic name
Metallic spinal interbody fusion cage
Model / reference
03.27.040
Primary DI / UDI-DI
07630030831829
510(k) Number
FDA product code
MAX
GMDN term
Metallic spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)