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Prime P2LXSF36

by MicroPort Orthopedics 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 NumberM684P2LXSF361 UDI-DI Date30 Jul 2018ListedStatusListed 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  • Withdrawn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
Prime
Generic Name
Non-constrained polyethylene acetabular liner
Model / Ref / Catalog
P2LXSF36
Primary DI / UDI-DI
M684P2LXSF361
510(k) Number
FDA Product Code
LZO, LPH
GMDN Term
Non-constrained polyethylene acetabular liner
Device Class
Class II
Regulation Number
888.3353, 888.3358
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 36 Millimeter

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K180798)

Show all (12)

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Properties

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

Other properties (7)

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