510(k) K111936
- Device
- ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
- Applicant
- ORTHO DEVELOPMENT
- 510(k) number
- K111936
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-09-21
- Date received
- 2011-07-08
- Regulation
- 888.3353
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOM HAUETER
- Address
- 12187 S. Business Park Dr. Draper UT US 84020 84020
FDA Registration Numbers#
- 1833920
- 9681642
- 3003998208
- 3005061536
- 3004188066
- 3002808022
- 3004513872
- 3009173317
- 2648920
- 1644408
- 3010287737
- 1226188
- 9616671
- 1047843
- 9610726
- 3016778562
- 3010041693
- 3010846112
- 3035366890
- 1226544
- 3026771806
- 3013302242
- 3003541440
- 9613369
- 3002807314
- 3008868758
- 3007200272
- 3009973336
- 3014644608
- 3003595343
- 3005323511
- 3004371426
- 3007923096
- 1643264
- 3010576282
- 3010386387
- 1649518
- 1827096
- 2134285
- 3011189525
- 1721676
- 3010375065
- 3014252644
- 3010468876
- 1221053
- 3009546990
- 3012425419
- 3005333358
- 3015167917
- 2246552
- 3038503932
- 1000200989
- 1818910
- 9681465
- 3012119238
- 3007366790
- 3026776
- 1828288
- 3022142628
- 1529009
- 3010178296
- 3016438761
- 3008421730
- 2133928
- 3042508254
- 1218882
- 3036773273
- 3012916784
- 1018470
- 3012523063
- 1531174
- 3002806535
- 3010206549
- 3002807315
- 3002807295
- 3020155054
- 3004748528
- 1835251
- 3005551626
- 3010531069
Source Documents#
Other 510(k) Records For Product Code LZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 |
| K260831 | Z1 Hip System | Zimmer, Inc. | 2026-06-16 |
| K260182 | Avenir® Müller Stem; Avenir Complete™ Hip System | Zimmer, Inc. | 2026-04-27 |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026-03-30 |
| K252401 | implaFit® short stems | Implantcast GmbH | 2026-03-12 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026-01-15 |
| K250450 | Coated hip implants | Medacta International S.A. | 2025-09-19 |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-08-07 |
| K251906 | Z1 Hip System | Zimmer, Inc. | 2025-07-18 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025-05-23 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025-05-16 |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025-05-15 |
| K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-05-02 |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025-04-18 |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2025-03-28 |
Legacy Summary#
summary
FDA Review#
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