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Delta Alumina Ceramic Heads Morse Taper 12/14

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 0513440Model MODULAR DELTA ALUMINA CERAMIC REVISION HEAD DIAM 44Ref 0510363Model FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 36 LONGRef 0514321Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 32 SHORTRef 0513280Model MODULAR DELTA ALUMINA CERAMIC REVISION HEAD DIAM 28Ref 0514324Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 32 EXTRA-LONGRef 0513004Model MODULAR SLEEVE 12/14 FOR REVISION HEAD EXTRA LONGRef 0514404Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 40 EXTRA-LONGRef 0513003Model MODULAR SLEEVE 12/14 FOR REVISION HEAD LONGRef 0514402Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 40 MEDIUMRef 0514323Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 32 LONGRef 0510283Model FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 28 LONGRef 0514183Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 22 LONGRef 0514442Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 44 MEDIUMRef 0510361Model FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 36 SHORTRef 0513320Model MODULAR DELTA ALUMINA CERAMIC REVISION HEAD DIAM 32Ref 0514182Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 22 MEDIUMRef 0510322Model FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 32 MEDIUMRef 0510362Model FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 36 MEDIUM

by Adler Ortho Spa

Identity

Trade Name
CERAMIC HEADS EUDAMED
Delta Alumina Ceramic Heads Morse Taper 12/14 FDA UDI
Generic Name
Ceramic femoral head prosthesis FDA UDI
Device Name
Delta Alumina Ceramic Head Ø36mm (Medium) FDA UDI
Delta Alumina Ceramic Head Ø32mm (Short) FDA UDI
Delta Alumina Ceramic Head Ø22mm (Medium) FDA UDI
Delta Alumina Ceramic Head Ø32mm (Long) FDA UDI
Delta Alumina Ceramic Head Ø22mm (Long) FDA UDI
Model / Reference
MODULAR DELTA ALUMINA CERAMIC REVISION HEAD DIAM 44 EUDAMED
0513440 EUDAMED
FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 36 LONG EUDAMED
0510363 EUDAMED
DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 32 SHORT EUDAMED
0514321 EUDAMED
MODULAR DELTA ALUMINA CERAMIC REVISION HEAD DIAM 28 EUDAMED
0513280 EUDAMED
DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 32 EXTRA-LONG EUDAMED
0514324 EUDAMED
MODULAR SLEEVE 12/14 FOR REVISION HEAD EXTRA LONG EUDAMED
0513004 EUDAMED
DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 40 EXTRA-LONG EUDAMED
0514404 EUDAMED
MODULAR SLEEVE 12/14 FOR REVISION HEAD LONG EUDAMED
0513003 EUDAMED
DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 40 MEDIUM EUDAMED
0514402 EUDAMED
DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 32 LONG EUDAMED
0514323 EUDAMED
FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 28 LONG EUDAMED
0510283 EUDAMED
DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 22 LONG EUDAMED
0514183 EUDAMED
DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 44 MEDIUM EUDAMED
0514442 EUDAMED
FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 36 SHORT EUDAMED
0510361 EUDAMED
MODULAR DELTA ALUMINA CERAMIC REVISION HEAD DIAM 32 EUDAMED
0513320 EUDAMED
DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 22 MEDIUM EUDAMED
0514182 EUDAMED
FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 32 MEDIUM EUDAMED
0510322 EUDAMED
FORTE ALUMINA CERAMIC HEAD 12/14 DIAM 36 MEDIUM EUDAMED
0510362 EUDAMED
Femoral Head FDA UDI
Description
Delta Alumina Ceramic Head Ø36mm (Medium) FDA UDI
Delta Alumina Ceramic Head Ø32mm (Short) FDA UDI
Delta Alumina Ceramic Head Ø22mm (Medium) FDA UDI
Delta Alumina Ceramic Head Ø32mm (Long) FDA UDI
Delta Alumina Ceramic Head Ø22mm (Long) FDA UDI

Identifiers

Catalog Number
0514362 FDA UDI
0514321 FDA UDI
0514182 FDA UDI
0514323 FDA UDI
0514183 FDA UDI
Primary DI / UDI-DI
08052532831265 EUDAMEDFDA UDI
08059606043548 EUDAMEDFDA UDI
08052532831289 EUDAMEDFDA UDI
08059606043555 EUDAMEDFDA UDI
08052532831135 EUDAMED
08052532830701 EUDAMED
08052532830930 EUDAMED
08052532831296 EUDAMED
08052532830923 EUDAMED
08052532831371 EUDAMED
08052532830916 EUDAMED
08052532831357 EUDAMED
08052532830640 EUDAMED
08052532831395 EUDAMED
08052532830688 EUDAMED
08052532830985 EUDAMED
08052532830664 EUDAMED
08052532830695 EUDAMED
08052532831319 FDA UDI
Basic UDI-DI
B-08052532831135 EUDAMED
B-08052532830701 EUDAMED
B-08052532831265 EUDAMED
B-08052532830930 EUDAMED
B-08052532831296 EUDAMED
B-08052532830923 EUDAMED
B-08052532831371 EUDAMED
B-08052532830916 EUDAMED
B-08052532831357 EUDAMED
B-08052532831289 EUDAMED
B-08052532830640 EUDAMED
B-08059606043555 EUDAMED
B-08052532831395 EUDAMED
B-08052532830688 EUDAMED
B-08052532830985 EUDAMED
B-08059606043548 EUDAMED
B-08052532830664 EUDAMED
B-08052532830695 EUDAMED
FDA Product Code
LPH FDA UDI
JDI FDA UDI
LZO FDA UDI
MBL FDA UDI
EMDN Code
P0908040504 REVISION FEMORAL HEADS EUDAMED
P090804050201 CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
P09088004 HIP PROSTHESES ADAPTERS (INCLUDING CONES AND SLEEVES) EUDAMED
GMDN Term
Ceramic femoral head prosthesis 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: Ceramic femoral head prosthesis

Delta Alumina Ceramic Heads Morse Taper 12/14 by Adler Ortho Spa — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Ceramic femoral head prosthesis.

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 (23)

  • FDA UDI 955f90bc-0b85-4622-96a3-db2fce76d273 35 fields · synced Aug 4, 2026
  • FDA UDI ce36e10c-2bc0-4530-9c6b-87862a4f3c04 35 fields · synced May 29, 2026
  • FDA UDI f3eb7849-2f56-4dcc-82aa-14431d1a9615 35 fields · synced May 30, 2026
  • FDA UDI 2d6abecf-f01f-405a-80c8-c0142d81663c 35 fields · synced May 30, 2026
  • FDA UDI d0ef6860-2718-4bfa-b2e2-bf66a653df8e 35 fields · synced May 30, 2026
  • EUDAMED 59f7cdf0-52df-441a-918b-13f01be54222 61 fields · synced Jun 20, 2026
  • EUDAMED 715f3a5e-3126-483f-bc08-f208a156646a 61 fields · synced Jul 8, 2026
  • EUDAMED 3bfdcda8-f85a-4096-82ba-f6b188b14de6 61 fields · synced Jul 9, 2026
  • EUDAMED f71bd462-a41c-475c-b6cb-13716169597b 61 fields · synced Jul 9, 2026
  • EUDAMED 1a161342-5f02-48c4-818c-f6bbf0da60d0 61 fields · synced Jul 9, 2026
  • EUDAMED 733d57ca-5cbf-4684-9a3d-70f49f4b9a15 61 fields · synced Jul 10, 2026
  • EUDAMED 73e9173b-5646-4608-bcd3-71c7d375113d 61 fields · synced Jul 16, 2026
  • EUDAMED b27d7399-6aab-4813-9678-95311a067986 61 fields · synced Jul 16, 2026
  • EUDAMED f0bfeccf-7282-42f3-8a26-f8e9a6d8bdab 61 fields · synced Jul 19, 2026
  • EUDAMED 2ae5c776-3094-48dd-ad79-366b74209cb0 61 fields · synced Jul 22, 2026
  • EUDAMED 27a46dcc-9fa5-4feb-8c63-e078c3a50f4a 61 fields · synced Jul 25, 2026
  • EUDAMED b593304d-b57b-4c82-bfb5-e805105edd89 61 fields · synced Jul 25, 2026
  • EUDAMED 962dd0c2-68b5-4036-a6ef-2039c76e8827 61 fields · synced Jul 26, 2026
  • EUDAMED 30882562-9734-4dfe-966e-0d754a696d17 61 fields · synced Jul 29, 2026
  • EUDAMED 43f57fa7-17f5-4950-ad64-ae9ced1bc664 61 fields · synced Jul 29, 2026
  • EUDAMED 910037a7-f0a7-4eaf-a6e0-848ce5973137 61 fields · synced Jul 29, 2026
  • EUDAMED ae7d5b30-53f6-4178-bc95-3fd84d93eaae 61 fields · synced Aug 3, 2026
  • EUDAMED 093a15cd-106b-4a87-b43f-d60685665989 61 fields · synced Aug 4, 2026