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Cross-Linked PE Insert

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 0942825Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 28 GR. DRef 0913211Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. FRef 0834025Model CROSS-LINKED PE INSERT FLAT DIAM. 40 GR. DRef 0943624Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 36 GR. CRef 0833625Model CROSS-LINKED PE INSERT FLAT DIAM. 36 GR. DRef 0843224Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. CRef 0833224Model CROSS-LINKED PE INSERT FLAT DIAM. 32 GR. CRef 0832824Model CROSS-LINKED PE INSERT FLAT DIAM. 28 GR. CRef 0942821Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 28 GR. ARef 0833225Model CROSS-LINKED PE INSERT FLAT DIAM. 32 GR. DRef 0843223Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. BRef 0832825Model CROSS-LINKED PE INSERT FLAT DIAM. 28 GR. DRef 0913611Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 36 GR. FRef 0832823Model CROSS-LINKED PE INSERT FLAT DIAM. 28 GR. BRef 0844024Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 40 GR. CRef 0844025Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 40 GR. DRef 0914011Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 40 GR. FRef 0833221Model CROSS-LINKED PE INSERT FLAT DIAM. 32 GR. ARef 0833624Model CROSS-LINKED PE INSERT FLAT DIAM. 36 GR. CRef 0914010Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 40 GR. ERef 0843221Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. ARef 0904010Model CROSS-LINKED PE INSERT FLAT DIAM. 40 GR. ERef 0903610Model CROSS-LINKED PE INSERT FLAT DIAM. 36 GR. ERef 0834024Model CROSS-LINKED PE INSERT FLAT DIAM. 40 GR. CRef 0902811Model CROSS-LINKED PE INSERT FLAT DIAM. 28 GR. FRef 0942824Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 28 GR. CRef 0833623Model CROSS-LINKED PE INSERT FLAT DIAM. 36 GR. BRef 0843225Model CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. D

by Adler Ortho Spa

Identity

Trade Name
PE INSERTS EUDAMED
Cross-Linked PE Insert FDA UDI
Generic Name
Non-constrained polyethylene acetabular liner FDA UDI
Device Name
Cross-Linked PE Insert 15° Lipped Diam. 28 Gr. B FDA UDI
Model / Reference
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 28 GR. D EUDAMED
0942825 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. F EUDAMED
0913211 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 40 GR. D EUDAMED
0834025 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 36 GR. C EUDAMED
0943624 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 36 GR. D EUDAMED
0833625 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. C EUDAMED
0843224 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 32 GR. C EUDAMED
0833224 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 28 GR. C EUDAMED
0832824 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 28 GR. A EUDAMED
0942821 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 32 GR. D EUDAMED
0833225 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. B EUDAMED
0843223 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 28 GR. D EUDAMED
0832825 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 36 GR. F EUDAMED
0913611 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 28 GR. B EUDAMED
0832823 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 40 GR. C EUDAMED
0844024 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 40 GR. D EUDAMED
0844025 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 40 GR. F EUDAMED
0914011 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 32 GR. A EUDAMED
0833221 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 36 GR. C EUDAMED
0833624 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 40 GR. E EUDAMED
0914010 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. A EUDAMED
0843221 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 40 GR. E EUDAMED
0904010 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 36 GR. E EUDAMED
0903610 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 40 GR. C EUDAMED
0834024 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 28 GR. F EUDAMED
0902811 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 28 GR. C EUDAMED
0942824 EUDAMED
CROSS-LINKED PE INSERT FLAT DIAM. 36 GR. B EUDAMED
0833623 EUDAMED
CROSS-LINKED PE INSERT 15° OFFSET DIAM. 32 GR. D EUDAMED
0843225 EUDAMED
Acetabular Insert FDA UDI
Description
Cross-Linked PE Insert 15° Lipped Diam. 28 Gr. B FDA UDI

Identifiers

Catalog Number
0884004 FDA UDI
Primary DI / UDI-DI
08051887565757 EUDAMED
08059606044750 EUDAMED
08051887560073 EUDAMED
08051887565887 EUDAMED
08052532839841 EUDAMED
08051887561209 EUDAMED
08052532839445 EUDAMED
08052532838943 EUDAMED
08051887565726 EUDAMED
08052532839452 EUDAMED
08051887561193 EUDAMED
08052532838950 EUDAMED
08059606044859 EUDAMED
08052532838936 EUDAMED
08051887561827 EUDAMED
08051887561834 EUDAMED
08059606044958 EUDAMED
08052532839421 EUDAMED
08052532839834 EUDAMED
08059606044941 EUDAMED
08051887561186 EUDAMED
08059606044545 EUDAMED
08059606044446 EUDAMED
08051887560066 EUDAMED
08059606044309 EUDAMED
08051887565740 EUDAMED
08052532839827 EUDAMED
08051887561216 EUDAMED
08050507130252 FDA UDI
Basic UDI-DI
B-08051887565757 EUDAMED
B-08059606044750 EUDAMED
B-08051887560073 EUDAMED
B-08051887565887 EUDAMED
B-08052532839841 EUDAMED
B-08051887561209 EUDAMED
B-08052532839445 EUDAMED
B-08052532838943 EUDAMED
B-08051887565726 EUDAMED
B-08052532839452 EUDAMED
B-08051887561193 EUDAMED
B-08052532838950 EUDAMED
B-08059606044859 EUDAMED
B-08052532838936 EUDAMED
B-08051887561827 EUDAMED
B-08051887561834 EUDAMED
B-08059606044958 EUDAMED
B-08052532839421 EUDAMED
B-08052532839834 EUDAMED
B-08059606044941 EUDAMED
B-08051887561186 EUDAMED
B-08059606044545 EUDAMED
B-08059606044446 EUDAMED
B-08051887560066 EUDAMED
B-08059606044309 EUDAMED
B-08051887565740 EUDAMED
B-08052532839827 EUDAMED
B-08051887561216 EUDAMED
FDA Product Code
LPH FDA UDI
JDI FDA UDI
LZO FDA UDI
MBL FDA UDI
EMDN Code
P090803040103 RETENTIVE POLYETHYLENE HIP PROSTHESES INSERTS, ANTI-DISLOCATION EUDAMED
P090803040101 STANDARD POLYETHYLENE HIP PROSTHESES INSERTS EUDAMED
P09088099 HIP PROSTHESES - OTHER ACCESSORIES EUDAMED
GMDN Term
Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
888.3358 FDA UDI
888.3350 FDA UDI
888.3353 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Non-constrained polyethylene acetabular liner

Cross-Linked PE Insert by Adler Ortho Spa — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Non-constrained polyethylene acetabular liner.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Adler Ortho Spa

Sources (29)

  • FDA UDI 08aa197d-b59e-4267-910d-979b5b032581 35 fields · synced Aug 3, 2026
  • EUDAMED 0e57ec1e-4e75-4851-bcf9-0842a7c47759 61 fields · synced Jul 8, 2026
  • EUDAMED 195871b1-6447-41cc-b180-cf770d56591a 61 fields · synced Jul 8, 2026
  • EUDAMED fe5a6360-774b-4586-b82d-944dcc07faf5 61 fields · synced Jul 10, 2026
  • EUDAMED adde2307-6f4d-45c6-872d-c061750c36e3 61 fields · synced Jul 10, 2026
  • EUDAMED c1041c34-a858-4278-82aa-33f1a2ebbb6b 61 fields · synced Jul 11, 2026
  • EUDAMED 535312b4-d087-4ab6-b03b-d7558f523b14 61 fields · synced Jul 12, 2026
  • EUDAMED aa9faa9f-538e-4d3a-b9f6-1c08b222b3c9 61 fields · synced Jul 13, 2026
  • EUDAMED eb3ff309-6b13-419a-badb-11a8e94d1d10 61 fields · synced Jul 15, 2026
  • EUDAMED 68477fef-616d-432c-8ae3-3f776fb1e96d 61 fields · synced Jul 15, 2026
  • EUDAMED 8aeabb27-68b1-4b8c-8465-77eede33adab 61 fields · synced Jul 17, 2026
  • EUDAMED 549b1b63-06e0-42ae-b136-81a3910c0485 61 fields · synced Jul 18, 2026
  • EUDAMED 5341989c-f354-4f46-82c4-8e0f4e921272 61 fields · synced Jul 19, 2026
  • EUDAMED 59b87468-994e-4e04-9d89-88bb0067fbd4 61 fields · synced Jul 19, 2026
  • EUDAMED 218627ba-58a3-4a92-9b81-4ab9b780ab7c 61 fields · synced Jul 20, 2026
  • EUDAMED e260a6ee-07ca-4853-9063-fd92e98aadf3 61 fields · synced Jul 22, 2026
  • EUDAMED 1fd597e3-138a-4432-9f52-b45dd5407ff2 61 fields · synced Jul 24, 2026
  • EUDAMED 4db6517f-a073-44fe-b522-fbb61e71b7d4 61 fields · synced Jul 25, 2026
  • EUDAMED dc95379b-021c-4532-954a-825918dc8d7d 61 fields · synced Jul 26, 2026
  • EUDAMED b1aa551b-ac0c-4cc9-974d-ee8c4f771904 61 fields · synced Jul 27, 2026
  • EUDAMED 39aac0ac-1bbf-4d18-a1e9-e5322f524aa1 61 fields · synced Jul 29, 2026
  • EUDAMED abc49494-f245-4e7d-8e79-20716447a223 61 fields · synced Jul 30, 2026
  • EUDAMED a85346d0-59e9-41d4-ae71-fb1dad7444bd 61 fields · synced Jul 31, 2026
  • EUDAMED 56a46063-b795-4598-8edc-96d0db34b4a9 61 fields · synced Jul 31, 2026
  • EUDAMED 5a5160f0-bec9-4623-9f0d-acf6bc2983f8 61 fields · synced Aug 1, 2026
  • EUDAMED 9cf937a4-c09d-4bab-a71e-3cfa6384496a 61 fields · synced Aug 2, 2026
  • EUDAMED 504d2217-3266-4705-99cd-a860c3a77e45 61 fields · synced Aug 3, 2026
  • EUDAMED 64df6f91-c07e-4b2b-879b-b10425c768eb 61 fields · synced Aug 3, 2026
  • EUDAMED 90214eb0-94ef-436a-8f02-81b544105cbc 61 fields · synced Aug 3, 2026