510(k) K052787
- Device
- ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5)
- Applicant
- EXACTECH, INC.
- 510(k) number
- K052787
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-27
- Date received
- 2005-10-03
- 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
- MARITZA ELIAS
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers#
- 3010065126
- 1000200989
- 3002808022
- 3018052045
- 3014272734
- 3007120646
- 3021386586
- 3009241418
- 3009173317
- 3031800723
- 3016778562
- 3010041693
- 3002807408
- 3009546990
- 9615800
- 3002807112
- 3010206549
- 3012319330
- 1057425
- 3015398319
- 3010047454
- 3008281151
- 3006946279
- 3015542154
- 3013176080
- 3007391088
- 3015167917
- 9681642
- 1000577893
- 3010531069
- 1835572
- 3017397663
- 3036756245
- 9616680
- 1827096
- 1226544
- 3004142400
- 9613369
- 3012119238
- 3010363503
- 2245304
- 1835251
- 1834331
- 1834379
- 3007353762
- 3043543260
- 3004638532
- 1061927
- 1220477
- 3008544874
- 3012275107
- 3011461101
- 1221053
- 3006395932
- 3026771806
- 2528981
- 2648920
- 3006946276
- 9616671
- 9617840
- 3012392319
- 3010536692
- 3012130008
- 3010386387
- 3004513872
- 3010576282
- 3011170410
- 3001278222
- 1020279
- 3010039400
- 1835444
- 3014315560
- 3006809628
- 3007913880
- 3006017180
- 3005718816
- 3008262872
- 3010057495
- 1000547811
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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