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Micro Seal Shell 60mm

by Signal Medical Corp.

Micro Seal Shell 60mm (WA-1-1029) is a metallic acetabular liner (FDA Class II; FDA product code LPH, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented) made by Signal Medical Corp., cleared under FDA 510(k) K971718 on 23 Jul 1997 and listed in FDA GUDID since 10 Oct 2017 (UDI-DI B046WA110290), active as of 23 Oct 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 23 Oct 2026

Documents

510(k) K971718

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB046WA110290 UDI-DI Date10 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK971718 Date23 Jul 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K971718 decided 23 Jul 1997 Active
  • FDA GUDID UDI-DI B046WA110290 listed 10 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K971718
  2. Listed FDA GUDID B046WA110290

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Micro Seal Shell
Generic name
Metallic acetabular liner
Model / Ref / Catalog
60mm, WA-1-1029
Primary DI / UDI-DI
B046WA110290
510(k) Number
FDA product code
LPH
GMDN term
Metallic acetabular liner
Device class
Class II
Regulation number
888.3358
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metallic acetabular liner

Cleared under the same submission (K971718)

and 8 more cleared under K971718

Similar devices in this category

Other devices filed under Metallic acetabular liner.

Other devices from Signal Medical Corp.

See all devices from Signal Medical Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)