510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bodycad Laboratories, Inc.

Quebec, CA

BODYCAD LABORATORIES, INC. appears in FDA device records in Quebec, CA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Bodycad Laboratories, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Laboratoires Bodycad, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 16 510(k) clearances for Bodycad Laboratories, Inc. between 2017 and 2025. The busiest year on record is 2021, with 4. The most recent is 2025, with 3.

Clearances by year, as a table
510(k) clearance decisions for Bodycad Laboratories, Inc., by decision year
YearClearances
20171
20193
20201
20214
20231
20243
20253
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253300Fine Osteotomy™HRSSubstantially Equivalent
K250394Fine TTO™PBFSubstantially Equivalent
K250923Fine Osteotomy™HRSSubstantially Equivalent
K241356Fine Osteotomy™HRSSubstantially Equivalent
K240703Fine Osteotomy™HRSSubstantially Equivalent
K240066Fine Osteotomy™PBFSubstantially Equivalent
K231314Fine Osteotomy™PBFSubstantially Equivalent
K212307BC Reflex Uni Knee SystemHSXSubstantially Equivalent
K211895BC Reflex Uni Knee SystemHSXSubstantially Equivalent
K211646FINE OsteotomyHRSSubstantially Equivalent
K203697BC Reflex Uni Knee SystemHSXSubstantially Equivalent
K193614FINE Osteotomy around the kneeHRSSubstantially Equivalent
K191996BC Reflex Uni Knee SystemHSXSubstantially Equivalent
K191150Bodycad Unicompartmental Knee SystemHSXSubstantially Equivalent
K181302Bodycad Unicompartmental Knee SystemHSXSubstantially Equivalent
K163700Bodycad Unicompartmental Knee SystemHSXSubstantially Equivalent

Registered establishments

FDA registered establishments for Bodycad Laboratories, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30120863983012086398BODYCAD LABORATORIES, INC.2035 rue du Haut-Bord, Quebec G1N 4R7 CA2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0244-2022Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain