Zimmer Medizinsysteme GmbH: FDA filings under this applicant name

FDA lists 13 510(k) clearances under the applicant name “Zimmer Medizinsysteme GmbH” (first 2016, latest 2026), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 131 days. Since 2017 the median was 138 days, against 108 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Zimmer Medizinsysteme GmbH took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.

Top product codes

Review panels

• Physical Medicine (9)
• General and Plastic Surgery (3)
• Gastroenterology and Urology (1)

Most recent Zimmer Medizinsysteme GmbH 510(k) clearances

3 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Zimmer Medizinsysteme GmbH.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Zimmer Medizinsysteme GmbH (a text match, not an official crosswalk):

• L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
• C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Zimmer, Inc. (422 510(k)s)
• Zimmer Spine, Inc. (43 510(k)s)
• Zimmer Dental, Inc. (40 510(k)s)
• Zimmer Biomet Spine, Inc. (15 510(k)s)
• Zimmer Trabecular Metal Technology (13 510(k)s)
• Zimmer Elektromedizin GmbH (12 510(k)s)
• Zimmer Trabecular (10 510(k)s)
• Zimmer Biomet (5 510(k)s)
• Zimmer Switzerland Manufacturing GmbH (4 510(k)s)
• Zimmer Cas (3 510(k)s)
• Zimmer Patient Care Division (3 510(k)s)
• Zimmer Austin, Inc. (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Zimmer Medizinsysteme GmbH?

FDA lists 13 510(k) clearances under the applicant name “Zimmer Medizinsysteme GmbH” (first 2016, latest 2026), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Zimmer Medizinsysteme GmbH?

The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmer Medizinsysteme GmbH is 131 days. Since 2017: 138 days, versus 108 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Zimmer Medizinsysteme GmbH?

The most frequent FDA product codes under this applicant name are NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 6); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 2); GEX (Powered Laser Surgical Instrument, 1).

Next steps

• See all 13 Zimmer Medizinsysteme GmbH clearances with predicates and recalls
• Run predicate analysis for product code NGX, Zimmer Medizinsysteme GmbH's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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